Vaginal Progesterone Versus Placebo for the Treatment of Vaginal Atrophy
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
If you are using any hormone replacement therapy, you will need to stop and complete a washout period before joining the study. The washout period is eight weeks for oral estrogen or progestin, four weeks for transdermal or local vaginal hormones, and eight weeks for progestin-containing intrauterine systems. Non-hormonal therapies like vaginal moisturizers cannot be used during the study, but vaginal lubricants for intercourse are allowed.
Is progesterone safe for human use?
Progesterone, especially in its micronized natural form, is generally considered safe for human use with fewer side effects compared to synthetic versions. Common side effects of synthetic progestins can include fatigue, fluid retention, and changes in mood, while natural progesterone tends to have milder effects.12345
How does the drug vaginal progesterone differ from other treatments for its condition?
Vaginal progesterone is unique because it is administered directly to the vagina, allowing for a direct transport to the uterus, which results in a preferential uptake of the hormone. This method provides effective support for the uterine lining with fewer systemic side effects compared to oral or synthetic progestins, making it particularly useful in conditions like infertility and hormone replacement therapy.678910
What data supports the effectiveness of the drug Vaginal Progesterone?
Research shows that using vaginal progesterone can significantly reduce the risk of spontaneous abortions (miscarriages) in women who have had previous miscarriages. In one study, only 9% of pregnancies treated with vaginal progesterone resulted in miscarriage, compared to 42% in untreated pregnancies.211121314
Who Is on the Research Team?
Wendy L Wolfman, MD, FRCSC
Principal Investigator
MOUNT SINAI HOSPITAL
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either vaginal progesterone or placebo suppositories for 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Placebo
- Vaginal Progesterone
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mount Sinai Hospital, Canada
Lead Sponsor