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Androgen

Intrarosa for Menopause

Phase 3
Waitlist Available
Research Sponsored by Center for Vulvovaginal Disorders
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

Tissues of the genitals of women are both androgen (testosterone) and estrogen dependent. The clitoris, vestibule, urethra, anterior vaginal wall, peri-urethral tissue, and pelvic floor all depend on androgens for normal function. In addition, the glands, which secrete lubrication during sexual arousal, also require androgens to function. Deficiencies of both estrogens and androgens occur naturally during menopause. Menopause-related deficiencies of these hormones lead to thinning in the tissues of the genital and urinary systems which have been termed Genitourinary Syndrome of Menopause (GSM). Patients with GSM will frequently complain of dryness and/or pain during sexual intercourse. Historically, GSM treatment involved both androgens and estrogens, However, over the past few decades estrogen based therapies have become much more common. More recently, clinical trials have demonstrated that local vaginal dehydroepiandrosterone (Intrarosa®) improves symptoms in menopausal women who have moderate to severe pain with intercourse. Intrarosa® vaginal inserts are a prescription medicine approved by the U.S. Food and Drug Administration (FDA) used in women after menopause to treat moderate to severe pain during sexual intercourse caused by changes in and around the vagina that happen with menopause.

Eligible Conditions
  • Menopause
  • Genitourinary Syndrome
  • Vulvovaginal Atrophy
  • Painful Intercourse

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes from baseline in antigen content of vulvar and vaginal cells
Changes from baseline in enzymatic content of vulvar and vaginal cells
Changes from baseline in morphological content of vulvar and vaginal cells
+1 more
Secondary outcome measures
Mean change from baseline in subject's scores on pain severity subscale VPAQ

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: IntrarosaActive Control1 Intervention
Daily intravaginal administration at bedtime of one insert containing 6.5mg (0.50%) prasterone for 26 weeks
Group II: PlaceboPlacebo Group1 Intervention
Daily intravaginal administration at bedtime of one insert containing placebo for 26 weeks

Find a Location

Who is running the clinical trial?

Center for Vulvovaginal DisordersLead Sponsor
7 Previous Clinical Trials
225 Total Patients Enrolled
EndoCeutics Inc.Industry Sponsor
9 Previous Clinical Trials
2,902 Total Patients Enrolled
Fernand Labrie, MDStudy DirectorEndoCeutics Inc.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~7 spots leftby Apr 2025