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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03287232

Enrollment

653

Registered

2017-09-19

Start date

2017-10-16

Completion date

2019-07-22

Last updated

2021-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoactive Sexual Desire Disorder

Keywords

Prasterone, DHEA, Menopause, Sexual Disorder

Brief summary

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

Interventions

DRUGPlacebo Vaginal Insert

Daily administration of a placebo vaginal insert.

DRUGPrasterone 6.5 mg (0.50%) Vaginal Insert

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

40 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Distress from low sexual desire	28 weeks	Change from Baseline in distress from low sexual desire evaluated by question 13 of FSDS-DAO.
Sexual desire	28 weeks	Change from Baseline in sexual desire evaluated by the FSFI desire domain (Questions 1 & 2).

Secondary

Measure	Time frame	Description
Satisfying sexual events (SSEs)	28 weeks	Change from Baseline in the number of SSEs from a daily log of sexual activity.

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026