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

NCT03619005 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2020-07-31

No results posted yet for this study

Summary

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

Conditions

  • Hypoactive Sexual Desire Disorder (HSDD)

Interventions

DRUG

Placebo Vaginal Insert

Daily administration of a placebo vaginal insert.

DRUG

Prasterone 6.5 mg (0.50%) Vaginal Insert

Daily administration of a 6.5 mg (0.50%) prasterone vaginal insert.

Sponsors & Collaborators

  • AMAG Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • EndoCeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Claude Labrie, M.D., Ph.D. · EndoCeutics Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-13
Primary Completion
2019-08-15
Completion
2019-12-06
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03619005 on ClinicalTrials.gov