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

Phase 3

Withdrawn

• Conditions: Hypoactive Sexual Desire Disorder (HSDD)
• Interventions: Drug: Placebo Vaginal Insert; Drug: Prasterone 6.5 mg (0.50%) Vaginal Insert

• Registration Number: NCT03619005
• 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

Study Timeline

• Study First Submitted: 2018-08-02
• Study First Submitted QC: 2018-08-02
• Study First Posted: 2018-08-07
• Study Start: 2018-11-13
• Primary Completion: 2019-08-15
• Study Completion: 2019-12-06
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-29
• Last Update Posted: 2020-07-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

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
Distress from low sexual desire	28 weeks	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.
Sexual desire	28 weeks	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.

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 (10)

Endoceutics site # 91; 🇺🇸 Savannah, Georgia, United States

Endoceutics site # 20; 🇺🇸 New York, New York, United States

Endoceutics site # 106; 🇺🇸 Huntsville, Alabama, United States

Endoceutics site # 114; 🇺🇸 Saint Petersburg, Florida, United States

Endoceutics site # 17; 🇺🇸 San Diego, California, United States

Endoceutics site # 125; 🇺🇸 New London, Connecticut, United States

Endoceutics site # 119; 🇺🇸 Roswell, Georgia, 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