Vaginal Progesterone Versus Placebo for the Treatment of Vaginal Atrophy (NCT02460302) | Clinical Trial Compass
WithdrawnPhase 2
Vaginal Progesterone Versus Placebo for the Treatment of Vaginal Atrophy
Stopped: Inadequate staffing and funds
Canada0Started 2016-12
Plain-language summary
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.
Who can participate
Age range45 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age greater than or equal to 45, unless the patient has had a bilateral oophorectomy
✓. Amenorrheic for greater than one year and/or FSH \> 40IU/mL
✓. Women who have had a bilateral oophorectomy will be eligible at any age
✓. Patients must have greater than or equal to two urogenital atrophy symptoms:
Exclusion criteria
✕. Age less than 45
✕. Systemic or local hormone replacement therapy use within three months of entry into study
✕. Known or suspected history of breast cancer
✕. Hormone dependent tumor
✕. Genital bleeding of unknown cause
✕. Current vaginal infection requiring treatment
✕. Known allergy to test constituents
What they're measuring
1
Perceived Improvement in most bothersome vulvovaginal symptom