Prasterone (DHEA) for the Treatment of Hypoactive Sexual Desire Disorder (HSDD)
- Conditions
- Hypoactive Sexual Desire Disorder
- Interventions
- Drug: Placebo Vaginal Insert
- Registration Number
- NCT03287232
- Lead Sponsor
- EndoCeutics Inc.
- Brief Summary
The primary objective is to confirm the efficacy of intravaginal prasterone (DHEA) on Hypoactive Sexual Desire Disorder (HSDD) in postmenopausal women.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 653
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Vaginal Insert - Prasterone Prasterone 6.5 mg (0.50%) Vaginal Insert -
- Primary Outcome Measures
Name Time Method Sexual desire 28 weeks Change from Baseline in sexual desire evaluated by the FSFI desire domain (Questions 1 \& 2).
Distress from low sexual desire 28 weeks Change from Baseline in distress from low sexual desire evaluated by question 13 of FSDS-DAO.
- Secondary Outcome Measures
Name Time Method Satisfying sexual events (SSEs) 28 weeks Change from Baseline in the number of SSEs from a daily log of sexual activity.
Trial Locations
- Locations (69)
Endoceutics site # 106
🇺🇸Huntsville, Alabama, United States
Endoceutics site # 104
🇺🇸Mobile, Alabama, United States
Endoceutics site # 108
🇺🇸Berkeley, California, United States
Endoceutics site #128
🇺🇸Los Angeles, California, United States
Endoceutics site # 121
🇺🇸Los Alamitos, California, United States
Endoceutics site # 95
🇺🇸Bradenton, Florida, United States
Endoceutics site # 125
🇺🇸New London, Connecticut, United States
Endoceutics site # 99
🇺🇸Fort Myers, Florida, United States
Endoceutics site # 26
🇺🇸Jacksonville, Florida, United States
Endoceutics site #118
🇺🇸Miami Lakes, Florida, United States
Endoceutics site # 120
🇺🇸Coral Gables, Florida, United States
Endoceutics site # 54
🇺🇸North Miami, Florida, United States
Endoceutics site # 92
🇺🇸Oviedo, Florida, United States
Endoceutics site # 90
🇺🇸West Palm Beach, Florida, United States
Endoceutics site # 89
🇺🇸West Palm Beach, Florida, United States
Endoceutics site # 114
🇺🇸Saint Petersburg, Florida, United States
Endoceutics site # 105
🇺🇸Sanford, Florida, United States
Endoceutics site # 80
🇺🇸West Palm Beach, Florida, United States
Endoceutics site # 107
🇺🇸Decatur, Georgia, United States
Endoceutics site # 119
🇺🇸Roswell, Georgia, United States
Endoceutics site # 91
🇺🇸Savannah, Georgia, United States
Endoceutics site # 23
🇺🇸Sandy Springs, Georgia, United States
Endoceutics site # 88
🇺🇸Lexington, Kentucky, United States
Endoceutics site # 86
🇺🇸Louisville, Kentucky, United States
Endoceutics site # 103
🇺🇸Boston, Massachusetts, United States
Endoceutics site # 22
🇺🇸Kalamazoo, Michigan, United States
Endoceutics site # 123
🇺🇸Portsmouth, New Hampshire, United States
Endoceutics site # 101
🇺🇸Berlin, New Jersey, United States
Endoceutics site # 50
🇺🇸Neptune, New Jersey, United States
Endoceutics site # 81
🇺🇸Plainsboro, New Jersey, United States
Endoceutics site # 20
🇺🇸New York, New York, United States
Endoceutics site # 58
🇺🇸Raleigh, North Carolina, United States
Endoceutics site # 110
🇺🇸Poughkeepsie, New York, United States
Endoceutics site # 97
🇺🇸Rochester, New York, United States
Endoceutics site # 116
🇺🇸Canton, Ohio, United States
Endoceutics site # 100
🇺🇸Cleveland, Ohio, United States
Endoceutics site # 5
🇺🇸Cleveland, Ohio, United States
Endoceutics site # 75
🇺🇸Philadelphia, Pennsylvania, United States
Endoceutics site # 93
🇺🇸Columbus, Ohio, United States
Endoceutics site # 126
🇺🇸Mount Pleasant, South Carolina, United States
Endoceutics site # 112
🇺🇸Myrtle Beach, South Carolina, United States
Endoceutics site # 64
🇺🇸Jackson, Tennessee, United States
Endoceutics site #124
🇺🇸Knoxville, Tennessee, United States
Endoceutics site # 82
🇺🇸Houston, Texas, United States
Endoceutics site # 3
🇺🇸Norfolk, Virginia, United States
Endoceutics site # 96
🇺🇸Charlottesville, Virginia, United States
Endoceutics site # 98
🇺🇸Norfolk, Virginia, United States
Endoceutics site # 76
🇺🇸Seattle, Washington, United States
Endoceutics site # 68
🇨🇦Sarnia, Ontario, Canada
Endoceutics site # 78
🇨🇦Québec, Quebec, Canada
Endoceutics site # 77
🇨🇦Québec, Quebec, Canada
Endoceutics site # 30
🇺🇸San Diego, California, United States
Endoceutics site # 17
🇺🇸San Diego, California, United States
Endoceutics site # 111
🇺🇸Wichita, Kansas, United States
Endoceutics site # 55
🇺🇸Wichita, Kansas, United States
Endoceutics site # 115
🇺🇸Fargo, North Dakota, United States
Endoceutics site #122
🇺🇸Nashville, Tennessee, United States
Endoceutics site # 102
🇺🇸San Antonio, Texas, United States
Endoceutics site # 36
🇺🇸Denver, Colorado, United States
Endoceutics site # 52
🇺🇸Denver, Colorado, United States
Endoceutics site # 44
🇺🇸New Brunswick, New Jersey, United States
Endoceutics site # 117
🇺🇸Tucson, Arizona, United States
Endoceutics site # 7
🇺🇸Washington, District of Columbia, United States
Endoceutics site # 127
🇺🇸Bluffton, South Carolina, United States
Endoceutics site # 94
🇺🇸Chattanooga, Tennessee, United States
Endoceutics site # 02
🇨🇦Québec, Quebec, Canada
Endoceutics site # 18
🇨🇦Lévis, Quebec, Canada
Endoceutics site # 11
🇨🇦Sherbrooke, Quebec, Canada
Endoceutics site # 60
🇺🇸Lake Worth, Florida, United States