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

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)

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

Study Overview

• Status: Withdrawn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

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • Endoceutics site # 106
  • California
    • San Diego, California, United States, 92120
      • EndoCeutics site # 17
  • Connecticut
    • New London, Connecticut, United States, 06320
      • Endoceutics site # 125
  • Florida
    • Saint Petersburg, Florida, United States, 33709
      • Endoceutics site # 114
  • Georgia
    • Roswell, Georgia, United States, 30075
      • Endoceutics site # 119
    • Savannah, Georgia, United States, 31406
      • Endoceutics site # 91
  • New York
    • New York, New York, United States, 10016
      • Endoceutics site # 20
  • North Dakota
    • Fargo, North Dakota, United States, 58103
      • Endoceutics site # 115
  • South Carolina
    • Bluffton, South Carolina, United States, 29910
      • Endoceutics site # 127
  • Texas
    • San Antonio, Texas, United States, 78229
      • Endoceutics site # 102

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 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.
Active Comparator: 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 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.	28 weeks
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.	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.
• Collaborators: AMAG Pharmaceuticals, Inc.
• Investigators: Study Chair: Claude Labrie, M.D., Ph.D., EndoCeutics Inc.

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): November 13, 2018
• Primary Completion (Actual): August 15, 2019
• Study Completion (Actual): December 6, 2019

Study Registration Dates

• First Submitted: August 2, 2018
• First Submitted That Met QC Criteria: August 2, 2018
• First Posted (Actual): August 7, 2018

Study Record Updates

• Last Update Posted (Actual): July 31, 2020
• Last Update Submitted That Met QC Criteria: July 29, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: DHEA; Prasterone; Menopause; HSDD; 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-245

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