search
Back to results

Bremelanotide in Premenopausal Women With Female Sexual Arousal Disorder and/or Hypoactive Sexual Desire Disorder

Primary Purpose

Female Sexual Arousal Disorder, Hypoactive Sexual Desire Disorder

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
bremelanotide
Sponsored by
Palatin Technologies, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Female Sexual Arousal Disorder focused on measuring FSAD, HSDD, female sexual dysfunction, FSD, Female Sexual Arousal Disorder, Hypoactive Sexual Desire Disorder

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Female, at least 21 years of age, and premenopausal Previously experienced sexual arousal during sexual activity and/or normal level of desire in the past for least 2 years.

Willing to engage in sexual activities Currently in stable relationship with a partner(male or female)for at least 6 months.

If subject has a male sexual partner, has recorded a score of "not impotent" or "minimally impotent" on Single-question Assessment of ED.

For at least 6 months before Screening, has met diagnostic criteria for FSAD, HSDD, or mixed FSAD/HSDD Has a negative serum pregnancy test (hCG) at Screening and, if subject's partner is male, has used a medically acceptable form of contraception for the 3 months before Screening (Visit 1), and is willing to continue for the duration of the trial and 1 month following the last dose of trial drug.

Has a normal pelvic examination. At Screening or documented within 12 months before Screening, has:normal Pap test results with or without history of positive HPV, dysplasia, or ASCUS that has resolved or been treated;Pap test results positive for ASCUS and negative for HPV;Pap test results positive for HPV AND no ASCUS or dysplasia on Pap or condyloma present upon examination.

At Screening and Visit 2, meets all necessary questionnaire scores.

Exclusion Criteria:

Medical condition that is unstable or uncontrolled despite current therapy. History of unresolved sexual trauma or abuse. Pregnant or nursing. Lifelong anorgasmia, vaginismus, sexual pain disorder, sexual aversion disorder, or persistent sexual arousal disorder.

Female sexual dysfunction caused by untreated endocrine disease. Has or has had any of the following: hepatitis C, other infectious hepatitis, infectious blood disorders such as HIV; myocardial infarction;stroke.

Has or has had any of the following within 12 months before Screening:chronic dyspareunia not attributable to vaginal dryness; pelvic inflammatory disease; chronic or complicated UTI, or an active STD other than herpes and condyloma; cervical dysplasia, including LGSIL and HGSIL and/or ASCUS with HPV; significant cervicitis as manifested by mucopurulent discharge from the cervix.

Has had any of the following within 6 months before Screening:≥ 2 outbreaks of genital herpes; occurrence/recurrence of clinically significant condyloma;clinically unstable angina or clinically unstable arrhythmia;significant CNS diseases;AST or ALT concentrations > 3 times the ULN;serum creatinine > 2.5 mg/dL;any other clinically significant abnormal laboratory result.

Has used prohibited medications within the 3 months before Screening:

Has currently active moderate to severe vaginitis or a clinically significant vaginal infection.

Has one or more significant gynecologic conditions . Is taking or has received treatment for psychosis, bipolar disorder, depression, and/or alcohol/substance abuse within 6 months before Screening.

Is currently receiving psychotherapy for the treatment of FSAD and/or HSDD. Has any of the following: Uncontrolled hypertension;Systolic BP of ≥ 140 mm Hg at Screening;Diastolic BP of ≥ 90 mm Hg at Screening; Treatment for hypertension that has changed in the 3 months before Screening.

Had a hysterectomy with bilateral oophorectomy. Had a hysterectomy without bilateral oophorectomy AND meets several other criteria.

Is taking contraceptives that have affected the menstrual cycle or caused amenorrhea AND did not have a normal menstrual cycle before starting the contraceptive medication.

Sites / Locations

  • Site 56
  • Site 26
  • Site 64
  • Site 45
  • Site 39
  • Site 25
  • Site 78
  • Site 16
  • Site 52
  • Site 73
  • Site 80
  • Site 12
  • Site 37
  • Site 40
  • Site 8
  • Site 75
  • Site 33
  • Site 32
  • Site 10
  • Site 27
  • Site 66
  • Site 61
  • Site 1
  • Site 82
  • Site 55
  • Site 70
  • Site 54
  • Site 63
  • Site 13
  • Site 48
  • Site 57
  • Site 9
  • Site 60
  • Site 74
  • Site 35
  • Site 72
  • Site 24
  • Site 18
  • Site 38
  • Site 3
  • Site 47
  • Site 23
  • Site 69
  • Site 71
  • Site 19
  • Site 30
  • Site 81
  • Site 2
  • Site 42
  • Site 77
  • Site 43
  • Site 58
  • Site 49
  • Site 53
  • Site 59
  • Site 76
  • Site 31
  • Site 17
  • Site 62
  • Site 50
  • Site 36
  • Site 7
  • Site 68
  • Site 65
  • Site 22
  • Site 4
  • Site 41
  • Site 21

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Placebo

bremelanotide arm 1

bremelanotide arm 2

bremelanotide arm 3

Arm Description

Same formulation as the investigation product but without the active ingredient, provided as pre-filled syringes containing 0.3 mL volume. Subjects will self-administer the placebo by SC injection in the same manner as the investigational product.

Low dose: Investigational product: Bremelanotide aqueous solution for subcutaneous (SC) injection, provided as pre-filled syringes containing 0.75 mg in 0.3 mL volume. Subjects will self-administer bremelanotide by SC injection into the anterior thigh or abdomen.

Middle dose: Investigational product: Bremelanotide aqueous solution for subcutaneous (SC) injection, provided as pre-filled syringes containing 1.25 mg in 0.3 mL volume. Subjects will self-administer bremelanotide by SC injection into the anterior thigh or abdomen.

High dose: Investigational product: Bremelanotide aqueous solution for subcutaneous (SC) injection, provided as pre-filled syringes containing 1.75 mg in 0.3 mL volume. Subjects will self-administer bremelanotide by SC injection into the anterior thigh or abdomen.

Outcomes

Primary Outcome Measures

The Primary Efficacy Endpoint is Change From Baseline to End of Study in the Number of Satisfying Sexual Events (SSE)
The primary efficacy endpoint is change from baseline to end of study in the number of satisfying sexual events (SSEs), computed as the number of events during the last 4 weeks of treatment with FSEP-R Q10 = "Yes" minus the number of baseline events with FSEP-R Q10 = "Yes." Efficacy analyses were done with the MITT population which consisted of all randomized subjects who took at least 1 dose of double-blind treatment after the 2 in-clinic doses of double-blind medication and who had at least 1 follow-up visit (Visit 10 or later) to ensure that FSEP-R data were reviewed and confirmed by the investigative site.

Secondary Outcome Measures

Change From Baseline to End-of-Study in Arousal Domain Score From Female Sexual Function Index
The FSFI is brief self-report questionnaire that measures female sexual function. The change from baseline to end of study in the arousal domain were obtained from the FSFI Q3 through Q6. The score range is 0-5. For each of the 2 time points, the score was computed programmatically using the algorithm described by Rosen [6], resulting in a score from 0 (min) to 6 (max).
Satisfaction With Arousal as Measured by GAQ Question 1
This is the change in Baseline to End-of-Study in Satisfaction with Arousal as measured by GAQ Question 1. GAQ (Global Assessment Questions) is a questionnaire that evaluates overall satisfaction level experienced while using the study drug. Question 1 is "Compared to the start of the study (prior to taking the study drug), how would you describe your satisfaction with your arousal while using the study drug?" The score range is 1 (very much worse) to 7 (very much better).
Desire Domain From Female Sexual Function Index
The FSFI is brief self-report questionnaire that measures female sexual function. The change from baseline to end of study in the desire domain were obtained from the FSFI Q1 and Q2. The score range is 1-5. For each of the 2 time points, the score was computed programmatically using the algorithm described by Rosen [6], resulting in a score from 0 (min) to 6 (max).
Satisfaction With Desire as Measured by GAQ Question 2
This is the change in Baseline to End-of-Study in Satisfaction with Desire as Measured by GAQ Question 2. GAQ (Global Assessment Questions) is a questionnaire that evaluates overall satisfaction level experienced while using the study drug. Question 2 is "Compared to the start of the study (prior to taking the study drug), how would you describe your satisfaction with your desire while using the study drug?" The score range is 1 (very much worse) to 7 (very much better).
Quality of Relationship With Partner as Measured by GAQ Question 4
This is the change in Baseline to End-of-Study in Quality of Relationship with Partner as Measured by GAQ Question 4. GAQ (Global Assessment Questions) is a questionnaire that evaluates overall satisfaction level experienced while using the study drug. Question 4 is "Compared to the start of the study (prior to taking the study drug), how has taking the study drug changed your relationship with your partner?" The score range is 1 (very much worse) to 7 (very much better).
FSDS-DAO Total Score
FSDS-DAO (Female Sexual Distress Scale - Desire/Arousal/Orgasm) is an assessment tool to measure female sexual distress. The change from baseline to end of study in the FSDS-DAO (total score) was measured. There are 15 questions, eg, "How often do you feel: Distressed about your sex life" and the score range was 0 (Never), 1 (Rarely), 2 (Occasionally), 3 (Frequently), 4 (Always). The score for each subject at each time point was computed as the sum of the scores from the 15 questions, resulting in a possible score at each time point between 0 and 60.

Full Information

First Posted
June 24, 2011
Last Updated
December 2, 2014
Sponsor
Palatin Technologies, Inc
search

1. Study Identification

Unique Protocol Identification Number
NCT01382719
Brief Title
Bremelanotide in Premenopausal Women With Female Sexual Arousal Disorder and/or Hypoactive Sexual Desire Disorder
Official Title
A Placebo-controlled, Randomized, Parallel Group, Dose-finding Trial to Evaluate the Efficacy and Safety of Subcutaneously Administered Bremelanotide in Premenopausal Women With FSAD (Female Sexual Arousal Disorder) and/or HSDD (Hypoactive Sexual Desire Disorder)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Palatin Technologies, Inc

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This trial is designed to evaluate the efficacy and safety of 3 fixed dose levels of bremelanotide, administered subcutaneously on an as-needed basis under conditions of home use, for the treatment of female sexual arousal disorder (FSAD), hypoactive sexual desire disorder (HSDD), or mixed FSAD/HSDD in premenopausal women.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Female Sexual Arousal Disorder, Hypoactive Sexual Desire Disorder
Keywords
FSAD, HSDD, female sexual dysfunction, FSD, Female Sexual Arousal Disorder, Hypoactive Sexual Desire Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
612 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Same formulation as the investigation product but without the active ingredient, provided as pre-filled syringes containing 0.3 mL volume. Subjects will self-administer the placebo by SC injection in the same manner as the investigational product.
Arm Title
bremelanotide arm 1
Arm Type
Experimental
Arm Description
Low dose: Investigational product: Bremelanotide aqueous solution for subcutaneous (SC) injection, provided as pre-filled syringes containing 0.75 mg in 0.3 mL volume. Subjects will self-administer bremelanotide by SC injection into the anterior thigh or abdomen.
Arm Title
bremelanotide arm 2
Arm Type
Experimental
Arm Description
Middle dose: Investigational product: Bremelanotide aqueous solution for subcutaneous (SC) injection, provided as pre-filled syringes containing 1.25 mg in 0.3 mL volume. Subjects will self-administer bremelanotide by SC injection into the anterior thigh or abdomen.
Arm Title
bremelanotide arm 3
Arm Type
Experimental
Arm Description
High dose: Investigational product: Bremelanotide aqueous solution for subcutaneous (SC) injection, provided as pre-filled syringes containing 1.75 mg in 0.3 mL volume. Subjects will self-administer bremelanotide by SC injection into the anterior thigh or abdomen.
Intervention Type
Drug
Intervention Name(s)
bremelanotide
Other Intervention Name(s)
PT-141
Intervention Description
Subjects will administer drug on an as needed basis, prior to anticipated sexual activity. Investigational product: Bremelanotide aqueous solution for subcutaneous (SC) injection, provided as pre-filled syringes containing 0.75, 1.25, or 1.75 mg in 0.3 mL volume. Subjects will self-administer bremelanotide by SC injection into the anterior thigh or abdomen. Placebo: Same formulation as the investigation product but without the active ingredient, provided as pre-filled syringes containing 0.3 mL volume. Subjects will self-administer the placebo by SC injection in the same manner as the investigational product.
Primary Outcome Measure Information:
Title
The Primary Efficacy Endpoint is Change From Baseline to End of Study in the Number of Satisfying Sexual Events (SSE)
Description
The primary efficacy endpoint is change from baseline to end of study in the number of satisfying sexual events (SSEs), computed as the number of events during the last 4 weeks of treatment with FSEP-R Q10 = "Yes" minus the number of baseline events with FSEP-R Q10 = "Yes." Efficacy analyses were done with the MITT population which consisted of all randomized subjects who took at least 1 dose of double-blind treatment after the 2 in-clinic doses of double-blind medication and who had at least 1 follow-up visit (Visit 10 or later) to ensure that FSEP-R data were reviewed and confirmed by the investigative site.
Time Frame
4 - 12 weeks from baseline to end of study (total study duration 20 weeks). Baseline was the 4-week single-blind placebo period.
Secondary Outcome Measure Information:
Title
Change From Baseline to End-of-Study in Arousal Domain Score From Female Sexual Function Index
Description
The FSFI is brief self-report questionnaire that measures female sexual function. The change from baseline to end of study in the arousal domain were obtained from the FSFI Q3 through Q6. The score range is 0-5. For each of the 2 time points, the score was computed programmatically using the algorithm described by Rosen [6], resulting in a score from 0 (min) to 6 (max).
Time Frame
4-12 weeks from baseline to end of study (total study duration 20 weeks)
Title
Satisfaction With Arousal as Measured by GAQ Question 1
Description
This is the change in Baseline to End-of-Study in Satisfaction with Arousal as measured by GAQ Question 1. GAQ (Global Assessment Questions) is a questionnaire that evaluates overall satisfaction level experienced while using the study drug. Question 1 is "Compared to the start of the study (prior to taking the study drug), how would you describe your satisfaction with your arousal while using the study drug?" The score range is 1 (very much worse) to 7 (very much better).
Time Frame
4-12 weeks from baseline to end of study (total study duration 20 weeks)
Title
Desire Domain From Female Sexual Function Index
Description
The FSFI is brief self-report questionnaire that measures female sexual function. The change from baseline to end of study in the desire domain were obtained from the FSFI Q1 and Q2. The score range is 1-5. For each of the 2 time points, the score was computed programmatically using the algorithm described by Rosen [6], resulting in a score from 0 (min) to 6 (max).
Time Frame
4-12 weeks from baseline to end of study (total study duration 20 weeks)
Title
Satisfaction With Desire as Measured by GAQ Question 2
Description
This is the change in Baseline to End-of-Study in Satisfaction with Desire as Measured by GAQ Question 2. GAQ (Global Assessment Questions) is a questionnaire that evaluates overall satisfaction level experienced while using the study drug. Question 2 is "Compared to the start of the study (prior to taking the study drug), how would you describe your satisfaction with your desire while using the study drug?" The score range is 1 (very much worse) to 7 (very much better).
Time Frame
4-12 weeks from baseline to end of study (total study duration 20 weeks)
Title
Quality of Relationship With Partner as Measured by GAQ Question 4
Description
This is the change in Baseline to End-of-Study in Quality of Relationship with Partner as Measured by GAQ Question 4. GAQ (Global Assessment Questions) is a questionnaire that evaluates overall satisfaction level experienced while using the study drug. Question 4 is "Compared to the start of the study (prior to taking the study drug), how has taking the study drug changed your relationship with your partner?" The score range is 1 (very much worse) to 7 (very much better).
Time Frame
4-12 weeks from baseline to end of study (total study duration 20 weeks)
Title
FSDS-DAO Total Score
Description
FSDS-DAO (Female Sexual Distress Scale - Desire/Arousal/Orgasm) is an assessment tool to measure female sexual distress. The change from baseline to end of study in the FSDS-DAO (total score) was measured. There are 15 questions, eg, "How often do you feel: Distressed about your sex life" and the score range was 0 (Never), 1 (Rarely), 2 (Occasionally), 3 (Frequently), 4 (Always). The score for each subject at each time point was computed as the sum of the scores from the 15 questions, resulting in a possible score at each time point between 0 and 60.
Time Frame
4 - 12 weeks from baseline to end of study (total study duration 20 weeks)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female, at least 21 years of age, and premenopausal Previously experienced sexual arousal during sexual activity and/or normal level of desire in the past for least 2 years. Willing to engage in sexual activities Currently in stable relationship with a partner(male or female)for at least 6 months. If subject has a male sexual partner, has recorded a score of "not impotent" or "minimally impotent" on Single-question Assessment of ED. For at least 6 months before Screening, has met diagnostic criteria for FSAD, HSDD, or mixed FSAD/HSDD Has a negative serum pregnancy test (hCG) at Screening and, if subject's partner is male, has used a medically acceptable form of contraception for the 3 months before Screening (Visit 1), and is willing to continue for the duration of the trial and 1 month following the last dose of trial drug. Has a normal pelvic examination. At Screening or documented within 12 months before Screening, has:normal Pap test results with or without history of positive HPV, dysplasia, or ASCUS that has resolved or been treated;Pap test results positive for ASCUS and negative for HPV;Pap test results positive for HPV AND no ASCUS or dysplasia on Pap or condyloma present upon examination. At Screening and Visit 2, meets all necessary questionnaire scores. Exclusion Criteria: Medical condition that is unstable or uncontrolled despite current therapy. History of unresolved sexual trauma or abuse. Pregnant or nursing. Lifelong anorgasmia, vaginismus, sexual pain disorder, sexual aversion disorder, or persistent sexual arousal disorder. Female sexual dysfunction caused by untreated endocrine disease. Has or has had any of the following: hepatitis C, other infectious hepatitis, infectious blood disorders such as HIV; myocardial infarction;stroke. Has or has had any of the following within 12 months before Screening:chronic dyspareunia not attributable to vaginal dryness; pelvic inflammatory disease; chronic or complicated UTI, or an active STD other than herpes and condyloma; cervical dysplasia, including LGSIL and HGSIL and/or ASCUS with HPV; significant cervicitis as manifested by mucopurulent discharge from the cervix. Has had any of the following within 6 months before Screening:≥ 2 outbreaks of genital herpes; occurrence/recurrence of clinically significant condyloma;clinically unstable angina or clinically unstable arrhythmia;significant CNS diseases;AST or ALT concentrations > 3 times the ULN;serum creatinine > 2.5 mg/dL;any other clinically significant abnormal laboratory result. Has used prohibited medications within the 3 months before Screening: Has currently active moderate to severe vaginitis or a clinically significant vaginal infection. Has one or more significant gynecologic conditions . Is taking or has received treatment for psychosis, bipolar disorder, depression, and/or alcohol/substance abuse within 6 months before Screening. Is currently receiving psychotherapy for the treatment of FSAD and/or HSDD. Has any of the following: Uncontrolled hypertension;Systolic BP of ≥ 140 mm Hg at Screening;Diastolic BP of ≥ 90 mm Hg at Screening; Treatment for hypertension that has changed in the 3 months before Screening. Had a hysterectomy with bilateral oophorectomy. Had a hysterectomy without bilateral oophorectomy AND meets several other criteria. Is taking contraceptives that have affected the menstrual cycle or caused amenorrhea AND did not have a normal menstrual cycle before starting the contraceptive medication.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Edelson, MD, FRCPC
Organizational Affiliation
Palatin Technologies, Inc
Official's Role
Study Director
Facility Information:
Facility Name
Site 56
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Site 26
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Site 64
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Site 45
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Site 39
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Site 25
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Site 78
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71901
Country
United States
Facility Name
Site 16
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
Site 52
City
National City
State/Province
California
ZIP/Postal Code
91950
Country
United States
Facility Name
Site 73
City
Newport Beach
State/Province
California
ZIP/Postal Code
92880
Country
United States
Facility Name
Site 80
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
Country
United States
Facility Name
Site 12
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Site 37
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Site 40
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Facility Name
Site 8
City
Avon
State/Province
Connecticut
ZIP/Postal Code
06117
Country
United States
Facility Name
Site 75
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06032
Country
United States
Facility Name
Site 33
City
New London
State/Province
Connecticut
ZIP/Postal Code
06320
Country
United States
Facility Name
Site 32
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20036
Country
United States
Facility Name
Site 10
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Site 27
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33916
Country
United States
Facility Name
Site 66
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32935
Country
United States
Facility Name
Site 61
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Site 1
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Site 82
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Site 55
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
Site 70
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60654
Country
United States
Facility Name
Site 54
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61602
Country
United States
Facility Name
Site 63
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46545
Country
United States
Facility Name
Site 13
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67226
Country
United States
Facility Name
Site 48
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
Site 57
City
Zachary
State/Province
Louisiana
ZIP/Postal Code
70791
Country
United States
Facility Name
Site 9
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21093
Country
United States
Facility Name
Site 60
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Site 74
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Site 35
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
Site 72
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89113
Country
United States
Facility Name
Site 24
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Site 18
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Site 38
City
Purchase
State/Province
New York
ZIP/Postal Code
10577
Country
United States
Facility Name
Site 3
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Site 47
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Site 23
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Site 69
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Site 71
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45249
Country
United States
Facility Name
Site 19
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Facility Name
Site 30
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Site 81
City
Englewood
State/Province
Ohio
ZIP/Postal Code
45322
Country
United States
Facility Name
Site 2
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Site 42
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Site 77
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15206
Country
United States
Facility Name
Site 43
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Site 58
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29650
Country
United States
Facility Name
Site 49
City
Mt. Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Site 53
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Site 59
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78414
Country
United States
Facility Name
Site 76
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Site 31
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Facility Name
Site 17
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Site 62
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Site 50
City
Murray
State/Province
Utah
ZIP/Postal Code
84123
Country
United States
Facility Name
Site 36
City
Sandy
State/Province
Utah
ZIP/Postal Code
84070
Country
United States
Facility Name
Site 7
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
Site 68
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Site 65
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
Facility Name
Site 22
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Site 4
City
North Vancouver
State/Province
British Columbia
ZIP/Postal Code
V7N 2H5
Country
Canada
Facility Name
Site 41
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 7G1
Country
Canada
Facility Name
Site 21
City
Burlington
State/Province
Ontario
ZIP/Postal Code
L7R4G1
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
34559353
Citation
Derogatis LR, Revicki DA, Rosen RC, Jordan R, Lucas J, Spana C. Psychometric validation of the Female Sexual Distress Scale-Desire/Arousal/Orgasm. J Patient Rep Outcomes. 2021 Sep 24;5(1):100. doi: 10.1186/s41687-021-00359-1.
Results Reference
derived
PubMed Identifier
27181790
Citation
Clayton AH, Althof SE, Kingsberg S, DeRogatis LR, Kroll R, Goldstein I, Kaminetsky J, Spana C, Lucas J, Jordan R, Portman DJ. Bremelanotide for female sexual dysfunctions in premenopausal women: a randomized, placebo-controlled dose-finding trial. Womens Health (Lond). 2016 Jun;12(3):325-37. doi: 10.2217/whe-2016-0018. Epub 2016 May 16.
Results Reference
derived

Learn more about this trial

Bremelanotide in Premenopausal Women With Female Sexual Arousal Disorder and/or Hypoactive Sexual Desire Disorder

We'll reach out to this number within 24 hrs