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

Last updated: April 7, 2021
Sponsor: EndoCeutics Inc.
Overall Status: Completed

Phase

3

Condition

Sexual Dysfunction

Dyskinesias

Treatment

N/A

Clinical Study ID

NCT03287232
ERC-242
  • Ages 40-80
  • Female

Study Summary

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

Eligibility Criteria

Inclusion

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 Design

Total Participants: 653
Study Start date:
October 16, 2017
Estimated Completion Date:
July 22, 2019

Connect with a study center

  • Endoceutics site # 68

    Sarnia, Ontario N7T 4X3
    Canada

    Site Not Available

  • Endoceutics site # 18

    Lévis, Quebec G6W 0M5
    Canada

    Site Not Available

  • Endoceutics site # 02

    Québec, Quebec G1S 2L6
    Canada

    Site Not Available

  • Endoceutics site # 77

    Québec, Quebec G1W 4R4
    Canada

    Site Not Available

  • Endoceutics site # 78

    Québec, Quebec G3K 2P8
    Canada

    Site Not Available

  • Endoceutics site # 11

    Sherbrooke, Quebec J1L 0H8
    Canada

    Site Not Available

  • Endoceutics site # 106

    Huntsville, Alabama 35801
    United States

    Site Not Available

  • Endoceutics site # 104

    Mobile, Alabama 36608
    United States

    Site Not Available

  • Endoceutics site # 117

    Tucson, Arizona 85712
    United States

    Site Not Available

  • Endoceutics site # 108

    Berkeley, California 84704
    United States

    Site Not Available

  • Endoceutics site # 121

    Los Alamitos, California 90720
    United States

    Site Not Available

  • Endoceutics site #128

    Los Angeles, California 90024
    United States

    Site Not Available

  • Endoceutics site # 17

    San Diego, California 92120
    United States

    Site Not Available

  • Endoceutics site # 30

    San Diego, California 92108
    United States

    Site Not Available

  • Endoceutics site # 36

    Denver, Colorado 80209
    United States

    Site Not Available

  • Endoceutics site # 52

    Denver, Colorado 80220
    United States

    Site Not Available

  • Endoceutics site # 125

    New London, Connecticut 06320
    United States

    Site Not Available

  • Endoceutics site # 7

    Washington, District of Columbia 20036
    United States

    Site Not Available

  • Endoceutics site # 95

    Bradenton, Florida 34201
    United States

    Site Not Available

  • Endoceutics site # 120

    Coral Gables, Florida 33134
    United States

    Site Not Available

  • Endoceutics site # 99

    Fort Myers, Florida 33912
    United States

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  • Endoceutics site # 26

    Jacksonville, Florida 32207
    United States

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  • Endoceutics site # 60

    Lake Worth, Florida 33461
    United States

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  • Endoceutics site #118

    Miami Lakes, Florida 33014
    United States

    Site Not Available

  • Endoceutics site # 54

    North Miami, Florida 33161
    United States

    Site Not Available

  • Endoceutics site # 92

    Oviedo, Florida 32765
    United States

    Site Not Available

  • Endoceutics site # 114

    Saint Petersburg, Florida 33709
    United States

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  • Endoceutics site # 105

    Sanford, Florida 32771
    United States

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  • Endoceutics site # 80

    West Palm Beach, Florida 33409
    United States

    Site Not Available

  • Endoceutics site # 89

    West Palm Beach, Florida 33401
    United States

    Site Not Available

  • Endoceutics site # 90

    West Palm Beach, Florida 33409
    United States

    Site Not Available

  • Endoceutics site # 107

    Decatur, Georgia 30030
    United States

    Site Not Available

  • Endoceutics site # 119

    Roswell, Georgia 30075
    United States

    Site Not Available

  • Endoceutics site # 23

    Sandy Springs, Georgia 30328
    United States

    Site Not Available

  • Endoceutics site # 91

    Savannah, Georgia 31406
    United States

    Site Not Available

  • Endoceutics site # 111

    Wichita, Kansas 67207
    United States

    Site Not Available

  • Endoceutics site # 55

    Wichita, Kansas 67226
    United States

    Site Not Available

  • Endoceutics site # 88

    Lexington, Kentucky 40509
    United States

    Site Not Available

  • Endoceutics site # 86

    Louisville, Kentucky 40291
    United States

    Site Not Available

  • Endoceutics site # 103

    Boston, Massachusetts 02131
    United States

    Site Not Available

  • Endoceutics site # 22

    Kalamazoo, Michigan 49009
    United States

    Site Not Available

  • Endoceutics site # 123

    Portsmouth, New Hampshire 03801
    United States

    Site Not Available

  • Endoceutics site # 101

    Berlin, New Jersey 08009
    United States

    Site Not Available

  • Endoceutics site # 50

    Neptune, New Jersey 07753
    United States

    Site Not Available

  • Endoceutics site # 44

    New Brunswick, New Jersey 08901
    United States

    Site Not Available

  • Endoceutics site # 81

    Plainsboro, New Jersey 08536
    United States

    Site Not Available

  • Endoceutics site # 20

    New York, New York 10016
    United States

    Site Not Available

  • Endoceutics site # 110

    Poughkeepsie, New York 12601
    United States

    Site Not Available

  • Endoceutics site # 97

    Rochester, New York 14609
    United States

    Site Not Available

  • Endoceutics site # 58

    Raleigh, North Carolina 27612
    United States

    Site Not Available

  • Endoceutics site # 115

    Fargo, North Dakota 58103
    United States

    Site Not Available

  • Endoceutics site # 116

    Canton, Ohio 44718
    United States

    Site Not Available

  • Endoceutics site # 100

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Endoceutics site # 5

    Cleveland, Ohio 44122
    United States

    Site Not Available

  • Endoceutics site # 93

    Columbus, Ohio 43213
    United States

    Site Not Available

  • Endoceutics site # 75

    Philadelphia, Pennsylvania 19114
    United States

    Site Not Available

  • Endoceutics site # 127

    Bluffton, South Carolina 29910
    United States

    Site Not Available

  • Endoceutics site # 126

    Mount Pleasant, South Carolina 29464
    United States

    Site Not Available

  • Endoceutics site # 112

    Myrtle Beach, South Carolina 29572
    United States

    Site Not Available

  • Endoceutics site # 94

    Chattanooga, Tennessee 37404
    United States

    Site Not Available

  • Endoceutics site # 64

    Jackson, Tennessee 38305
    United States

    Site Not Available

  • Endoceutics site #124

    Knoxville, Tennessee 37920
    United States

    Site Not Available

  • Endoceutics site #122

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Endoceutics site # 82

    Houston, Texas 77030
    United States

    Site Not Available

  • Endoceutics site # 102

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Endoceutics site # 96

    Charlottesville, Virginia 22942
    United States

    Site Not Available

  • Endoceutics site # 3

    Norfolk, Virginia 23507
    United States

    Site Not Available

  • Endoceutics site # 98

    Norfolk, Virginia 23507
    United States

    Site Not Available

  • Endoceutics site # 76

    Seattle, Washington 98105
    United States

    Site Not Available

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