Vaginal Progesterone Versus Placebo for the Treatment of Vaginal Atrophy

• Status: Unknown status
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mount Sinai Hospital, Canada
• Treatments: Progesterone

Criteria

Inclusion criteria:

1. Age greater than or equal to 45, unless the patient has had a bilateral oophorectomy

2. Amenorrheic for greater than one year and/or FSH > 40IU/mL

3. Women who have had a bilateral oophorectomy will be eligible at any age

4. Patients must have greater than or equal to two urogenital atrophy symptoms:

• vaginal dryness

• vaginal irritation

• vaginal soreness

• dyspareunia

Exclusion criteria:

1. Age less than 45

2. Systemic or local hormone replacement therapy use within three months of entry into study

3. Known or suspected history of breast cancer

4. Hormone dependent tumor

5. Genital bleeding of unknown cause

6. Current vaginal infection requiring treatment

7. Known allergy to test constituents

8. Serious disease or chronic condition that could interfere with compliance

9. Active thrombophlebitis, or history of a hormone-associated thrombophlebitis

10. Kidney disease

11. Liver dysfunction or disease

12. High LDL levels

Women who have used systemic or local hormone replacement therapy will be ineligible for participation in the study. If these women wish to participate, they must undergo a washout period. This would be as follows:

• eight weeks for oral estrogen and/or progestin therapy

• four weeks for transdermal or local vaginal hormone therapies

• eight weeks for progestin containing intrauterine system

Participants who are completing a washout period must complete the study questionnaire following the washout period.

Women will not be allowed to continue or commence use of non-hormonal therapies, including vaginal moisturizers, while they are in the study, However, we will allow the use of vaginal lubricants for sexual intercourse. Their use will be recorded on the patient questionnaire.