The primary objective is to confirm the efficacy of intravaginal prasterone (DHEA) on Hypoactive Sexual Desire Disorder (HSDD) in postmenopausal women.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Daily administration of a placebo vaginal insert.
Daily administration of a 6.5 mg (0.50%) prasterone vaginal insert.
Endoceutics site # 106
Huntsville, Alabama, United States
Endoceutics site # 17
San Diego, California, United States
Endoceutics site # 125
New London, Connecticut, United States
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.
Time frame: 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.
Time frame: 28 weeks
Satisfying sexual events (SSEs)
Change from Baseline in the number of SSEs from a daily log of sexual activity.
Time frame: 28 weeks
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Endoceutics site # 114
St. Petersburg, Florida, United States
Endoceutics site # 119
Roswell, Georgia, United States
Endoceutics site # 91
Savannah, Georgia, United States
Endoceutics site # 20
New York, New York, United States
Endoceutics site # 115
Fargo, North Dakota, United States
Endoceutics site # 127
Bluffton, South Carolina, United States
Endoceutics site # 102
San Antonio, Texas, United States