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

Prasterone (DHEA) for the Treatment of Hypoactive Sexual Desire Disorder (HSDD) - (Placebo-Controlled, Double Blind and Randomized Phase III Study of Intravaginal Prasterone)

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

Study Overview

• Status: Completed
• Conditions: Hypoactive Sexual Desire Disorder
• Intervention / Treatment: Drug: Placebo Vaginal Insert; Drug: Prasterone 6.5 mg (0.50%) Vaginal Insert

• Study Type: Interventional
• Enrollment (Actual): 653
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Sarnia, Ontario, Canada, N7T 4X3
      • EndoCeutics site # 68
  • Quebec
    • Lévis, Quebec, Canada, G6W 0M5
      • EndoCeutics site # 18
    • Québec, Quebec, Canada, G1S 2L6
      • EndoCeutics site # 02
    • Québec, Quebec, Canada, G1W 4R4
      • EndoCeutics site # 77
    • Québec, Quebec, Canada, G3K 2P8
      • EndoCeutics site # 78
    • Sherbrooke, Quebec, Canada, J1L 0H8
      • EndoCeutics site # 11
• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • Endoceutics site # 106
    • Mobile, Alabama, United States, 36608
      • Endoceutics site # 104
  • Arizona
    • Tucson, Arizona, United States, 85712
      • Endoceutics site # 117
  • California
    • Berkeley, California, United States, 84704
      • Endoceutics site # 108
    • Los Alamitos, California, United States, 90720
      • Endoceutics site # 121
    • Los Angeles, California, United States, 90024
      • Endoceutics site #128
    • San Diego, California, United States, 92108
      • EndoCeutics site # 30
    • San Diego, California, United States, 92120
      • EndoCeutics site # 17
  • Colorado
    • Denver, Colorado, United States, 80209
      • EndoCeutics site # 36
    • Denver, Colorado, United States, 80220
      • EndoCeutics site # 52
  • Connecticut
    • New London, Connecticut, United States, 06320
      • Endoceutics site # 125
  • District of Columbia
    • Washington, District of Columbia, United States, 20036
      • Endoceutics site # 7
  • Florida
    • Bradenton, Florida, United States, 34201
      • Endoceutics site # 95
    • Coral Gables, Florida, United States, 33134
      • Endoceutics site # 120
    • Fort Myers, Florida, United States, 33912
      • Endoceutics site # 99
    • Jacksonville, Florida, United States, 32207
      • EndoCeutics site # 26
    • Lake Worth, Florida, United States, 33461
      • EndoCeutics site # 60
    • Miami Lakes, Florida, United States, 33014
      • Endoceutics site #118
    • North Miami, Florida, United States, 33161
      • EndoCeutics site # 54
    • Oviedo, Florida, United States, 32765
      • Endoceutics site # 92
    • Saint Petersburg, Florida, United States, 33709
      • Endoceutics site # 114
    • Sanford, Florida, United States, 32771
      • Endoceutics site # 105
    • West Palm Beach, Florida, United States, 33401
      • Endoceutics site # 89
    • West Palm Beach, Florida, United States, 33409
      • EndoCeutics site # 80
    • West Palm Beach, Florida, United States, 33409
      • Endoceutics site # 90
  • Georgia
    • Decatur, Georgia, United States, 30030
      • Endoceutics site # 107
    • Roswell, Georgia, United States, 30075
      • Endoceutics site # 119
    • Sandy Springs, Georgia, United States, 30328
      • EndoCeutics site # 23
    • Savannah, Georgia, United States, 31406
      • Endoceutics site # 91
  • Kansas
    • Wichita, Kansas, United States, 67207
      • Endoceutics site # 111
    • Wichita, Kansas, United States, 67226
      • EndoCeutics site # 55
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • Endoceutics site # 88
    • Louisville, Kentucky, United States, 40291
      • EndoCeutics site # 86
  • Massachusetts
    • Boston, Massachusetts, United States, 02131
      • Endoceutics site # 103
  • Michigan
    • Kalamazoo, Michigan, United States, 49009
      • EndoCeutics site # 22
  • New Hampshire
    • Portsmouth, New Hampshire, United States, 03801
      • Endoceutics site # 123
  • New Jersey
    • Berlin, New Jersey, United States, 08009
      • Endoceutics site # 101
    • Neptune, New Jersey, United States, 07753
      • EndoCeutics site # 50
    • New Brunswick, New Jersey, United States, 08901
      • EndoCeutics site # 44
    • Plainsboro, New Jersey, United States, 08536
      • EndoCeutics site # 81
  • New York
    • New York, New York, United States, 10016
      • Endoceutics site # 20
    • Poughkeepsie, New York, United States, 12601
      • Endoceutics site # 110
    • Rochester, New York, United States, 14609
      • Endoceutics site # 97
  • North Carolina
    • Raleigh, North Carolina, United States, 27612
      • Endoceutics site # 58
  • North Dakota
    • Fargo, North Dakota, United States, 58103
      • Endoceutics site # 115
  • Ohio
    • Canton, Ohio, United States, 44718
      • Endoceutics site # 116
    • Cleveland, Ohio, United States, 44106
      • Endoceutics site # 100
    • Cleveland, Ohio, United States, 44122
      • Endoceutics site # 5
    • Columbus, Ohio, United States, 43213
      • Endoceutics site # 93
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19114
      • EndoCeutics site # 75
  • South Carolina
    • Bluffton, South Carolina, United States, 29910
      • Endoceutics site # 127
    • Mount Pleasant, South Carolina, United States, 29464
      • Endoceutics site # 126
    • Myrtle Beach, South Carolina, United States, 29572
      • Endoceutics site # 112
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Endoceutics site # 94
    • Jackson, Tennessee, United States, 38305
      • EndoCeutics site # 64
    • Knoxville, Tennessee, United States, 37920
      • Endoceutics site #124
    • Nashville, Tennessee, United States, 37203
      • Endoceutics site #122
  • Texas
    • Houston, Texas, United States, 77030
      • EndoCeutics site # 82
    • San Antonio, Texas, United States, 78229
      • Endoceutics site # 102
  • Virginia
    • Charlottesville, Virginia, United States, 22942
      • Endoceutics site # 96
    • Norfolk, Virginia, United States, 23507
      • Endoceutics site # 3
    • Norfolk, Virginia, United States, 23507
      • Endoceutics site # 98
  • Washington
    • Seattle, Washington, United States, 98105
      • EndoCeutics site # 76

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo Vaginal Insert; Daily administration of a placebo vaginal insert.
Experimental: Prasterone	Drug: Prasterone 6.5 mg (0.50%) Vaginal Insert; Daily administration of a 6.5 mg (0.50%) prasterone vaginal insert.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sexual desire	Change from Baseline in sexual desire evaluated by the FSFI desire domain (Questions 1 & 2).	28 weeks
Distress from low sexual desire	Change from Baseline in distress from low sexual desire evaluated by question 13 of FSDS-DAO.	28 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfying sexual events (SSEs)	Change from Baseline in the number of SSEs from a daily log of sexual activity.	28 weeks

Collaborators and Investigators

• Sponsor: EndoCeutics Inc.
• Investigators: Study Chair: Claude Labrie, M.D., Ph.D., EndoCeutics Inc.; Principal Investigator: Leonard R. Derogatis, Ph.D., Maryland Center for Sexual Health

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2017
• Primary Completion (Actual): March 8, 2019
• Study Completion (Actual): July 22, 2019

Study Registration Dates

• First Submitted: September 15, 2017
• First Submitted That Met QC Criteria: September 15, 2017
• First Posted (Actual): September 19, 2017

Study Record Updates

• Last Update Posted (Actual): April 9, 2021
• Last Update Submitted That Met QC Criteria: April 7, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: DHEA; Prasterone; Menopause; Sexual Disorder
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Disease; Hypokinesia; Sexual Dysfunctions, Psychological; Physiological Effects of Drugs; Immunologic Factors; Adjuvants, Immunologic; Dehydroepiandrosterone
• Other Study ID Numbers: ERC-242

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No