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Prasterone (DHEA) for the Treatment of Hypoactive Sexual Desire Disorder (HSDD) - Second Study

Primary Purpose

Hypoactive Sexual Desire Disorder (HSDD)

Status
Withdrawn
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Placebo Vaginal Insert
Prasterone 6.5 mg (0.50%) Vaginal Insert
Sponsored by
EndoCeutics Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypoactive Sexual Desire Disorder (HSDD) focused on measuring Prasterone, DHEA, Menopause, Sexual Disorder, HSDD

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria (main criteria):

  • Postmenopausal women (hysterectomized or not).
  • Women between 40 and 80 years of age.
  • Being in a stable relationship with the opportunity for sexual activity or masturbation at least once a month during the last 6 months or longer (before screening visit) and during the following 8 months.
  • Diagnosis of HSDD confirmed by a qualified clinician.
  • Willing to participate in the study and sign an informed consent.

Exclusion Criteria (main criteria):

  • Chronic or acute life stress or major life change that could have interfered and continues to interfere significantly with sexual activity.
  • Taking drugs which could be responsible for HSDD.
  • Severe medical condition which can explain the loss of sexual desire.
  • The administration of any investigational drug within 30 days of screening visit.
  • Clinically significant abnormal serum biochemistry, urinalysis or hematology.

Sites / Locations

  • Endoceutics site # 106
  • Endoceutics site # 17
  • Endoceutics site # 125
  • Endoceutics site # 114
  • Endoceutics site # 119
  • Endoceutics site # 91
  • Endoceutics site # 20
  • Endoceutics site # 115
  • Endoceutics site # 127
  • Endoceutics site # 102

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Prasterone

Arm Description

Outcomes

Primary Outcome Measures

Sexual desire
Change from Baseline in sexual desire as evaluated by Questions 1 & 2 of the 19-items questionnaire titled Female Sexual Function Index (FSFI). For this outcome, Question 1 and Question 2 (corresponding to the desire domain) will be graded from 1 to 5 (score range) and then be multiplied by 0.6 (domain factor). The desire domain (sum of scores from Questions 1 & 2) has a minimum score of 1.2 and a maximum score of 6. Higher values represent a better outcome.
Distress from low sexual desire
Change from Baseline in distress from low sexual desire as evaluated by Question 13 of the 15-items questionnaire titled Female Sexual Distress Scale - Desire Arousal Orgasm (FSDS-DAO). For this outcome, Question 13 is graded from 0 to 4 and a lower value represents a better outcome.

Secondary Outcome Measures

Satisfying sexual events (SSEs)
Change from Baseline in the number of SSEs from a daily log of sexual activity.

Full Information

First Posted
August 2, 2018
Last Updated
July 29, 2020
Sponsor
EndoCeutics Inc.
Collaborators
AMAG Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03619005
Brief Title
Prasterone (DHEA) for the Treatment of Hypoactive Sexual Desire Disorder (HSDD) - Second Study
Official Title
Prasterone (DHEA) for the Treatment of Hypoactive Sexual Desire Disorder (HSDD) - Second Study (Placebo-Controlled, Double-Blind and Randomized Phase III Study of Intravaginal Prasterone)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Business decision to not continue this study (only few subjects were screened).
Study Start Date
November 13, 2018 (Actual)
Primary Completion Date
August 15, 2019 (Actual)
Study Completion Date
December 6, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EndoCeutics Inc.
Collaborators
AMAG Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective is to confirm the efficacy of intravaginal prasterone (DHEA) on Hypoactive Sexual Desire Disorder (HSDD) in postmenopausal women.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoactive Sexual Desire Disorder (HSDD)
Keywords
Prasterone, DHEA, Menopause, Sexual Disorder, HSDD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Prasterone
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Placebo Vaginal Insert
Intervention Description
Daily administration of a placebo vaginal insert.
Intervention Type
Drug
Intervention Name(s)
Prasterone 6.5 mg (0.50%) Vaginal Insert
Intervention Description
Daily administration of a 6.5 mg (0.50%) prasterone vaginal insert.
Primary Outcome Measure Information:
Title
Sexual desire
Description
Change from Baseline in sexual desire as evaluated by Questions 1 & 2 of the 19-items questionnaire titled Female Sexual Function Index (FSFI). For this outcome, Question 1 and Question 2 (corresponding to the desire domain) will be graded from 1 to 5 (score range) and then be multiplied by 0.6 (domain factor). The desire domain (sum of scores from Questions 1 & 2) has a minimum score of 1.2 and a maximum score of 6. Higher values represent a better outcome.
Time Frame
28 weeks
Title
Distress from low sexual desire
Description
Change from Baseline in distress from low sexual desire as evaluated by Question 13 of the 15-items questionnaire titled Female Sexual Distress Scale - Desire Arousal Orgasm (FSDS-DAO). For this outcome, Question 13 is graded from 0 to 4 and a lower value represents a better outcome.
Time Frame
28 weeks
Secondary Outcome Measure Information:
Title
Satisfying sexual events (SSEs)
Description
Change from Baseline in the number of SSEs from a daily log of sexual activity.
Time Frame
28 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria (main criteria): Postmenopausal women (hysterectomized or not). Women between 40 and 80 years of age. Being in a stable relationship with the opportunity for sexual activity or masturbation at least once a month during the last 6 months or longer (before screening visit) and during the following 8 months. Diagnosis of HSDD confirmed by a qualified clinician. Willing to participate in the study and sign an informed consent. Exclusion Criteria (main criteria): Chronic or acute life stress or major life change that could have interfered and continues to interfere significantly with sexual activity. Taking drugs which could be responsible for HSDD. Severe medical condition which can explain the loss of sexual desire. The administration of any investigational drug within 30 days of screening visit. Clinically significant abnormal serum biochemistry, urinalysis or hematology.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claude Labrie, M.D., Ph.D.
Organizational Affiliation
EndoCeutics Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Endoceutics site # 106
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Endoceutics site # 17
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Endoceutics site # 125
City
New London
State/Province
Connecticut
ZIP/Postal Code
06320
Country
United States
Facility Name
Endoceutics site # 114
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
Endoceutics site # 119
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30075
Country
United States
Facility Name
Endoceutics site # 91
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Endoceutics site # 20
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Endoceutics site # 115
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
Endoceutics site # 127
City
Bluffton
State/Province
South Carolina
ZIP/Postal Code
29910
Country
United States
Facility Name
Endoceutics site # 102
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19424093
Citation
Labrie F, Archer D, Bouchard C, Fortier M, Cusan L, Gomez JL, Girard G, Baron M, Ayotte N, Moreau M, Dube R, Cote I, Labrie C, Lavoie L, Berger L, Gilbert L, Martel C, Balser J. Effect of intravaginal dehydroepiandrosterone (Prasterone) on libido and sexual dysfunction in postmenopausal women. Menopause. 2009 Sep-Oct;16(5):923-31. doi: 10.1097/gme.0b013e31819e85c6.
Results Reference
background
PubMed Identifier
26597311
Citation
Labrie F, Derogatis L, Archer DF, Koltun W, Vachon A, Young D, Frenette L, Portman D, Montesino M, Cote I, Parent J, Lavoie L, Beauregard A, Martel C, Vaillancourt M, Balser J, Moyneur E; Members of the VVA Prasterone Research Group. Effect of Intravaginal Prasterone on Sexual Dysfunction in Postmenopausal Women with Vulvovaginal Atrophy. J Sex Med. 2015 Dec;12(12):2401-12. doi: 10.1111/jsm.13045. Epub 2015 Nov 23.
Results Reference
background
PubMed Identifier
26725467
Citation
Bouchard C, Labrie F, Derogatis L, Girard G, Ayotte N, Gallagher J, Cusan L, Archer DF, Portman D, Lavoie L, Beauregard A, Cote I, Martel C, Vaillancourt M, Balser J, Moyneur E; VVA Prasterone Group. Effect of intravaginal dehydroepiandrosterone (DHEA) on the female sexual function in postmenopausal women: ERC-230 open-label study. Horm Mol Biol Clin Investig. 2016 Mar;25(3):181-90. doi: 10.1515/hmbci-2015-0044.
Results Reference
background

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Prasterone (DHEA) for the Treatment of Hypoactive Sexual Desire Disorder (HSDD) - Second Study

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