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

NCT03287232 | Completed Phase 3 FDA Drug

• 1 other identifier: ERC-242
• Study Type: interventional
• Target: 653
• Locations: 2 countries
• Sites: 69

Brief Summary

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

Conditions

Hypoactive Sexual Desire Disorder

Keywords

Prasterone; DHEA; Menopause; Sexual Disorder

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Satisfying sexual events (SSEs)

  28 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo Vaginal Insert

Prasterone

EXPERIMENTAL

Drug: Prasterone 6.5 mg (0.50%) Vaginal Insert

Interventions

Placebo Vaginal Insert DRUG

Daily administration of a placebo vaginal insert.

Placebo

Prasterone 6.5 mg (0.50%) Vaginal Insert DRUG

Daily administration of a 6.5 mg (0.50%) prasterone vaginal insert.

Prasterone

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• EndoCeutics Inc.: lead

Study Sites (69)

Endoceutics site # 106

Huntsville, Alabama, 35801, United States

Location

Endoceutics site # 104

Mobile, Alabama, 36608, United States

Location

Endoceutics site # 117

Tucson, Arizona, 85712, United States

Location

Endoceutics site # 108

Berkeley, California, 84704, United States

Location

Endoceutics site # 121

Los Alamitos, California, 90720, United States

Location

Endoceutics site #128

Los Angeles, California, 90024, United States

Location

Endoceutics site # 30

San Diego, California, 92108, United States

Location

Endoceutics site # 17

San Diego, California, 92120, United States

Location

Endoceutics site # 36

Denver, Colorado, 80209, United States

Location

Endoceutics site # 52

Denver, Colorado, 80220, United States

Location

Endoceutics site # 125

New London, Connecticut, 06320, United States

Location

Endoceutics site # 7

Washington D.C., District of Columbia, 20036, United States

Location

Endoceutics site # 95

Bradenton, Florida, 34201, United States

Location

Endoceutics site # 120

Coral Gables, Florida, 33134, United States

Location

Endoceutics site # 99

Fort Myers, Florida, 33912, United States

Location

Endoceutics site # 26

Jacksonville, Florida, 32207, United States

Location

Endoceutics site # 60

Lake Worth, Florida, 33461, United States

Location

Endoceutics site #118

Miami Lakes, Florida, 33014, United States

Location

Endoceutics site # 54

North Miami, Florida, 33161, United States

Location

Endoceutics site # 92

Oviedo, Florida, 32765, United States

Location

Endoceutics site # 105

Sanford, Florida, 32771, United States

Location

Endoceutics site # 114

St. Petersburg, Florida, 33709, United States

Location

Endoceutics site # 89

West Palm Beach, Florida, 33401, United States

Location

Endoceutics site # 80

West Palm Beach, Florida, 33409, United States

Location

Endoceutics site # 90

West Palm Beach, Florida, 33409, United States

Location

Endoceutics site # 107

Decatur, Georgia, 30030, United States

Location

Endoceutics site # 119

Roswell, Georgia, 30075, United States

Location

Endoceutics site # 23

Sandy Springs, Georgia, 30328, United States

Location

Endoceutics site # 91

Savannah, Georgia, 31406, United States

Location

Endoceutics site # 111

Wichita, Kansas, 67207, United States

Location

Endoceutics site # 55

Wichita, Kansas, 67226, United States

Location

Endoceutics site # 88

Lexington, Kentucky, 40509, United States

Location

Endoceutics site # 86

Louisville, Kentucky, 40291, United States

Location

Endoceutics site # 103

Boston, Massachusetts, 02131, United States

Location

Endoceutics site # 22

Kalamazoo, Michigan, 49009, United States

Location

Endoceutics site # 123

Portsmouth, New Hampshire, 03801, United States

Location

Endoceutics site # 101

Berlin, New Jersey, 08009, United States

Location

Endoceutics site # 50

Neptune City, New Jersey, 07753, United States

Location

Endoceutics site # 44

New Brunswick, New Jersey, 08901, United States

Location

Endoceutics site # 81

Plainsboro, New Jersey, 08536, United States

Location

Endoceutics site # 20

New York, New York, 10016, United States

Location

Endoceutics site # 110

Poughkeepsie, New York, 12601, United States

Location

Endoceutics site # 97

Rochester, New York, 14609, United States

Location

Endoceutics site # 58

Raleigh, North Carolina, 27612, United States

Location

Endoceutics site # 115

Fargo, North Dakota, 58103, United States

Location

Endoceutics site # 116

Canton, Ohio, 44718, United States

Location

Endoceutics site # 100

Cleveland, Ohio, 44106, United States

Location

Endoceutics site # 5

Cleveland, Ohio, 44122, United States

Location

Endoceutics site # 93

Columbus, Ohio, 43213, United States

Location

Endoceutics site # 75

Philadelphia, Pennsylvania, 19114, United States

Location

Endoceutics site # 127

Bluffton, South Carolina, 29910, United States

Location

Endoceutics site # 126

Mt. Pleasant, South Carolina, 29464, United States

Location

Endoceutics site # 112

Myrtle Beach, South Carolina, 29572, United States

Location

Endoceutics site # 94

Chattanooga, Tennessee, 37404, United States

Location

Endoceutics site # 64

Jackson, Tennessee, 38305, United States

Location

Endoceutics site #124

Knoxville, Tennessee, 37920, United States

Location

Endoceutics site #122

Nashville, Tennessee, 37203, United States

Location

Endoceutics site # 82

Houston, Texas, 77030, United States

Location

Endoceutics site # 102

San Antonio, Texas, 78229, United States

Location

Endoceutics site # 96

Charlottesville, Virginia, 22942, United States

Location

Endoceutics site # 3

Norfolk, Virginia, 23507, United States

Location

Endoceutics site # 98

Norfolk, Virginia, 23507, United States

Location

Endoceutics site # 76

Seattle, Washington, 98105, United States

Location

Endoceutics site # 68

Sarnia, Ontario, N7T 4X3, Canada

Location

Endoceutics site # 18

Lévis, Quebec, G6W 0M5, Canada

Location

Endoceutics site # 02

Québec, Quebec, G1S 2L6, Canada

Location

Endoceutics site # 77

Québec, Quebec, G1W 4R4, Canada

Location

Endoceutics site # 78

Québec, Quebec, G3K 2P8, Canada

Location

Endoceutics site # 11

Sherbrooke, Quebec, J1L 0H8, Canada

Location

Related Publications (3)

• 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.

  PMID: 19424093 BACKGROUND

• 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.

  PMID: 26597311 BACKGROUND

• 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.

  PMID: 26725467 BACKGROUND

MeSH Terms

Conditions

Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological

Interventions

Dehydroepiandrosterone

Condition Hierarchy (Ancestors)

Mental Disorders; Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 17-Ketosteroids; Ketosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones

Study Officials

• Claude Labrie, M.D., Ph.D.

  EndoCeutics Inc.

  STUDY CHAIR

• Leonard R. Derogatis, Ph.D.

  Maryland Center for Sexual Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2017
• First Posted: September 19, 2017
• Study Start: October 16, 2017
• Primary Completion: March 8, 2019
• Study Completion: July 22, 2019
• Last Updated: April 9, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (63); CA (6)