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OpenTrials
Completed

NCT Number: NCT03287232

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

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

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Key information

Conditions

Hypoactive Sexual Desire Disorder Genital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

40 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Endoceutics site # 68, Sarnia, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(main criteria):

  • Postmenopausal women (hysterectomized or not).
  • Women between 40 and 80 years of age.
  • Being in a stable relationship with the opportunity for sexual activity or masturbation at least once a month during the last 6 months or longer (before screening visit) and during the following 8 months.
  • Diagnosis of HSDD confirmed by a qualified clinician.
  • Willing to participate in the study and sign an informed consent.

Exclusion criteria

(main criteria):

  • Chronic or acute life stress or major life change that could have interfered and continues to interfere significantly with sexual activity.
  • Taking drugs which could be responsible for HSDD.
  • Severe medical condition which can explain the loss of sexual desire.
  • The administration of any investigational drug within 30 days of screening visit.
  • Clinically significant abnormal serum biochemistry, urinalysis or hematology.

Treatment and study plan

Placebo Vaginal Insert

Drug

Daily administration of a placebo vaginal insert.

Prasterone 6.5 mg (0.50%) Vaginal Insert

Drug

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

Primary outcomes

  1. Sexual desire

    Time frame: 28 weeks

    Change from Baseline in sexual desire evaluated by the FSFI desire domain (Questions 1 & 2).

  2. Distress from low sexual desire

    Time frame: 28 weeks

    Change from Baseline in distress from low sexual desire evaluated by question 13 of FSDS-DAO.

Secondary outcomes

  1. Satisfying sexual events (SSEs)

    Time frame: 28 weeks

    Change from Baseline in the number of SSEs from a daily log of sexual activity.

Sponsors and collaborators

Lead sponsor

EndoCeutics Inc.

Industry

Registry information

Official study title

Prasterone (DHEA) for the Treatment of Hypoactive Sexual Desire Disorder (HSDD) - (Placebo-Controlled, Double Blind and Randomized Phase III Study of Intravaginal Prasterone)

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 19, 2017
Registry last updated
Apr 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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