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

Phase 3

Completed

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

Study Timeline

• Study First Submitted: 2017-09-15
• Study First Submitted QC: 2017-09-15
• Study First Posted: 2017-09-19
• Study Start: 2017-10-16
• Primary Completion: 2019-03-08
• Study Completion: 2019-07-22
• Disposition First Submitted: 2020-07-29
• Disposition First Submitted QC: 2020-07-29
• Disposition First Posted: 2020-08-03
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-07
• Last Update Posted: 2021-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 653

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
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 # 117; 🇺🇸 Tucson, Arizona, United States

Endoceutics site # 108; 🇺🇸 Berkeley, California, United States

Endoceutics site # 121; 🇺🇸 Los Alamitos, California, United States

Endoceutics site #128; 🇺🇸 Los Angeles, California, United States

Endoceutics site # 30; 🇺🇸 San Diego, California, United States

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

Endoceutics site # 36; 🇺🇸 Denver, Colorado, United States

Endoceutics site # 52; 🇺🇸 Denver, Colorado, United States

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