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

Primary Purpose

Hypoactive Sexual Desire Disorder

Status
Completed
Phase
Phase 3
Locations
International
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 focused on measuring Prasterone, DHEA, Menopause, Sexual Disorder

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 # 104
  • Endoceutics site # 117
  • Endoceutics site # 108
  • Endoceutics site # 121
  • Endoceutics site #128
  • Endoceutics site # 30
  • Endoceutics site # 17
  • Endoceutics site # 36
  • Endoceutics site # 52
  • Endoceutics site # 125
  • Endoceutics site # 7
  • Endoceutics site # 95
  • Endoceutics site # 120
  • Endoceutics site # 99
  • Endoceutics site # 26
  • Endoceutics site # 60
  • Endoceutics site #118
  • Endoceutics site # 54
  • Endoceutics site # 92
  • Endoceutics site # 114
  • Endoceutics site # 105
  • Endoceutics site # 89
  • Endoceutics site # 80
  • Endoceutics site # 90
  • Endoceutics site # 107
  • Endoceutics site # 119
  • Endoceutics site # 23
  • Endoceutics site # 91
  • Endoceutics site # 111
  • Endoceutics site # 55
  • Endoceutics site # 88
  • Endoceutics site # 86
  • Endoceutics site # 103
  • Endoceutics site # 22
  • Endoceutics site # 123
  • Endoceutics site # 101
  • Endoceutics site # 50
  • Endoceutics site # 44
  • Endoceutics site # 81
  • Endoceutics site # 20
  • Endoceutics site # 110
  • Endoceutics site # 97
  • Endoceutics site # 58
  • Endoceutics site # 115
  • Endoceutics site # 116
  • Endoceutics site # 100
  • Endoceutics site # 5
  • Endoceutics site # 93
  • Endoceutics site # 75
  • Endoceutics site # 127
  • Endoceutics site # 126
  • Endoceutics site # 112
  • Endoceutics site # 94
  • Endoceutics site # 64
  • Endoceutics site #124
  • Endoceutics site #122
  • Endoceutics site # 82
  • Endoceutics site # 102
  • Endoceutics site # 96
  • Endoceutics site # 3
  • Endoceutics site # 98
  • Endoceutics site # 76
  • Endoceutics site # 68
  • Endoceutics site # 18
  • Endoceutics site # 02
  • Endoceutics site # 77
  • Endoceutics site # 78
  • Endoceutics site # 11

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Prasterone

Arm Description

Outcomes

Primary Outcome Measures

Sexual desire
Change from Baseline in sexual desire evaluated by the FSFI desire domain (Questions 1 & 2).
Distress from low sexual desire
Change from Baseline in distress from low sexual desire evaluated by question 13 of FSDS-DAO.

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
September 15, 2017
Last Updated
April 7, 2021
Sponsor
EndoCeutics Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03287232
Brief Title
Prasterone (DHEA) for the Treatment of Hypoactive Sexual Desire Disorder (HSDD)
Official Title
Prasterone (DHEA) for the Treatment of Hypoactive Sexual Desire Disorder (HSDD) - (Placebo-Controlled, Double Blind and Randomized Phase III Study of Intravaginal Prasterone)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
October 16, 2017 (Actual)
Primary Completion Date
March 8, 2019 (Actual)
Study Completion Date
July 22, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EndoCeutics 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
Keywords
Prasterone, DHEA, Menopause, Sexual Disorder

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Prasterone
Arm Type
Experimental
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 evaluated by the FSFI desire domain (Questions 1 & 2).
Time Frame
28 weeks
Title
Distress from low sexual desire
Description
Change from Baseline in distress from low sexual desire evaluated by question 13 of FSDS-DAO.
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
First Name & Middle Initial & Last Name & Degree
Leonard R. Derogatis, Ph.D.
Organizational Affiliation
Maryland Center for Sexual Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Endoceutics site # 106
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Endoceutics site # 104
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Endoceutics site # 117
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Endoceutics site # 108
City
Berkeley
State/Province
California
ZIP/Postal Code
84704
Country
United States
Facility Name
Endoceutics site # 121
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Facility Name
Endoceutics site #128
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
Endoceutics site # 30
City
San Diego
State/Province
California
ZIP/Postal Code
92108
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 # 36
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Facility Name
Endoceutics site # 52
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
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 # 7
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20036
Country
United States
Facility Name
Endoceutics site # 95
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34201
Country
United States
Facility Name
Endoceutics site # 120
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Endoceutics site # 99
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Endoceutics site # 26
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Endoceutics site # 60
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33461
Country
United States
Facility Name
Endoceutics site #118
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Endoceutics site # 54
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Endoceutics site # 92
City
Oviedo
State/Province
Florida
ZIP/Postal Code
32765
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 # 105
City
Sanford
State/Province
Florida
ZIP/Postal Code
32771
Country
United States
Facility Name
Endoceutics site # 89
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Endoceutics site # 80
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Endoceutics site # 90
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Endoceutics site # 107
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
Endoceutics site # 119
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30075
Country
United States
Facility Name
Endoceutics site # 23
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Endoceutics site # 91
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Endoceutics site # 111
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Endoceutics site # 55
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67226
Country
United States
Facility Name
Endoceutics site # 88
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
Endoceutics site # 86
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40291
Country
United States
Facility Name
Endoceutics site # 103
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Facility Name
Endoceutics site # 22
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49009
Country
United States
Facility Name
Endoceutics site # 123
City
Portsmouth
State/Province
New Hampshire
ZIP/Postal Code
03801
Country
United States
Facility Name
Endoceutics site # 101
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Endoceutics site # 50
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07753
Country
United States
Facility Name
Endoceutics site # 44
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Endoceutics site # 81
City
Plainsboro
State/Province
New Jersey
ZIP/Postal Code
08536
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 # 110
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Facility Name
Endoceutics site # 97
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
Endoceutics site # 58
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
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 # 116
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Endoceutics site # 100
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Endoceutics site # 5
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Endoceutics site # 93
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Endoceutics site # 75
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
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 # 126
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Endoceutics site # 112
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
Endoceutics site # 94
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Endoceutics site # 64
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Endoceutics site #124
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Endoceutics site #122
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Endoceutics site # 82
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Endoceutics site # 102
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Endoceutics site # 96
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22942
Country
United States
Facility Name
Endoceutics site # 3
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Endoceutics site # 98
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Endoceutics site # 76
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Endoceutics site # 68
City
Sarnia
State/Province
Ontario
ZIP/Postal Code
N7T 4X3
Country
Canada
Facility Name
Endoceutics site # 18
City
Lévis
State/Province
Quebec
ZIP/Postal Code
G6W 0M5
Country
Canada
Facility Name
Endoceutics site # 02
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1S 2L6
Country
Canada
Facility Name
Endoceutics site # 77
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1W 4R4
Country
Canada
Facility Name
Endoceutics site # 78
City
Québec
State/Province
Quebec
ZIP/Postal Code
G3K 2P8
Country
Canada
Facility Name
Endoceutics site # 11
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1L 0H8
Country
Canada

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

Learn more about this trial

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

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