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Progestogen

Vaginal Progesterone for Atrophic Vaginitis

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

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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Perceived Improvement in most bothersome vulvovaginal symptom
Secondary outcome measures
Change in physician-assigned vaginal health index score based on a detailed rating scale
Other outcome measures
Change in vaginal maturation index value
Change in vaginal pH values

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

Find a Location

Who is running the clinical trial?

Mount Sinai Hospital, CanadaLead Sponsor
196 Previous Clinical Trials
67,608 Total Patients Enrolled
Wendy L Wolfman, MD, FRCSCPrincipal InvestigatorMOUNT SINAI HOSPITAL
~0 spots leftby Sep 2025
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