Vaginal Progesterone Versus Placebo for the Treatment of Vaginal Atrophy

Phase 2

Waitlist Available

Led By Wendy L Wolfman, MD, FRCSC

Research Sponsored by Mount Sinai Hospital, Canada

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 12 weeks

Awards & highlights

All Individual Drugs Already Approved

Summary

This trial is testing vaginal progesterone suppositories to treat post-menopausal women with vaginal dryness and inflammation who cannot use or do not respond to estrogen treatments. Progesterone may help by reducing inflammation and improving the health of the vaginal lining. Recent studies suggest that vaginally administered progesterone is selectively distributed to the uterus, potentially offering benefits in hormone replacement therapy. The goal is to find an effective alternative treatment for these women.

Eligible Conditions

Atrophic Vaginitis
Menopause
Vulvovaginal Atrophy

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Perceived Improvement in most bothersome vulvovaginal symptom

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Vaginal ProgesteroneExperimental Treatment1 Intervention

In the experimental arm, the participants will be randomized (1:1 allocation) to receive a vaginal progesterone suppository (100mg) as the intervention. Participants will be instructed to insert the vaginal suppository into the vagina, as high as is comfortable for the patient. They are to insert the drug three days per week, on Monday, Wednesday and Fridays, preferably at bedtime. Patients will record the use of their medications. This will be done for the study period of 12 weeks.

Group II: Placebo ComparatorPlacebo Group1 Intervention

In the placebo arm, the participants will be randomized (1:1 allocation) to receive a vaginal suppository (100mg) containing hard fat without any active hormonal ingredient as the intervention. Participants will be instructed to insert the vaginal suppository into the vagina, as high as is comfortable for the patient. They are to insert the placebo three days per week, on Monday, Wednesday and Fridays, preferably at bedtime. Patients will record the use of their medications. This will be done for the study period of 12 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Progesterone

FDA approved

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