Vaginal Progesterone Versus Placebo for the Treatment of Vaginal Atrophy
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|ClinicalTrials.gov Identifier: NCT02460302|
Recruitment Status : Recruiting
First Posted : June 2, 2015
Last Update Posted : April 29, 2019
Atrophic vaginitis affects the majority of post-menopausal women. It is characterized by dryness and inflammation of the vagina, with thinning of the vaginal tissues. Atrophic vaginitis is caused by the decreased effect of estrogens post menopause. Traditionally, local estrogens have been used to treat atrophic vaginitis
Studies have shown that there are progesterone receptors in vaginal tissues. The use of progesterone to treat atrophic vaginitis has not yet been studied. However, its use has been studied in other populations including as a fertility medication in pregnant women.
There is a significant group of women who cannot use, choose not to use, or do not respond to estrogenic therapies. The goal of this study is to evaluate the efficacy of vaginal progesterone in the treatment of urogenital atrophy, compared to placebo. This study is a randomized, double-blind, placebo controlled trial. The ultimate goal is to expand the treatment options for patients with symptoms of vaginal atrophy.
|Condition or disease||Intervention/treatment||Phase|
|Atrophic Vaginitis Menopause Vulvovaginal Atrophy||Drug: Vaginal progesterone Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Vaginal Progesterone Versus Placebo for the Treatment of Vaginal Atrophy - a Double Blind Randomized Control Trial|
|Study Start Date :||December 2016|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||December 2020|
Experimental: Vaginal Progesterone
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.
Drug: Vaginal progesterone
Micronized vaginal progesterone 100mg inserted vaginally
Other Name: Oripro
Placebo Comparator: Placebo Comparator
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.
Placebo suppository inserted vaginally
- Perceived Improvement in most bothersome vulvovaginal symptom [ Time Frame: 12 weeks ]Improvement in patient-identified most bothersome symptom (vaginal dryness, itching, soreness, pain with sexual activity)
- Change in physician-assigned vaginal health index score based on a detailed rating scale [ Time Frame: 12 weeks ]
- Change in vaginal maturation index value [ Time Frame: 12 weeks ]
- Change in vaginal pH values [ Time Frame: 12 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02460302
|Contact: Wendy L Wolfman, MD, FRCSC||416-586-4800 ext firstname.lastname@example.org|
|Contact: Sheryl Hewko, RN||416-586-4800 ext email@example.com|
|Principal Investigator:||Wendy L Wolfman, MD, FRCSC||MOUNT SINAI HOSPITAL|