Efficacy & Tolerability of Progesterone Vaginal Tablets (Endometrin®) in Menopausal Women Treated by Estrogen Replacement Therapy - Phase II Comparative Study
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Rabin Medical Center
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Comparing the proportion of women with endometrial thickness not exceeding 8mm and change not exceeding 3mm between the two groups.
Study Overview
Brief Summary
The objective of the study is to confirm that the efficacy of vaginal progesterone is at least as good as oral progesterone in order to protect the endometrium of uncontrolled proliferation and prevent endometrial cancer.
Detailed Description
Estrogen Replacement Therapy must be opposed by progesterone in order to protect the endometrium of uncontrolled proliferation and prevent endometrial cancer, in women with an intact uterus.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 45 Years to 60 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Women who are candidates for Hormone Replacement Therapy due to menopausal symptoms.
- •Women with an intact uterus.
- •No menses within the 12 months preceding screening visit and /or FSH >30 IU/L.
- •Endometrial thickness ≤ 5 mm.
Exclusion Criteria
- •Submucosal fibroid/s that applying pressure and affecting endometrial thickness
- •Other medication that could affect estrogenic state.
Arms & Interventions
Progesterone vaginal tablet
Group A - Daily use of Endometrin 100 mg progesterone vaginal tablet, and Estrofem orally.
Intervention: progesterone (Drug)
Activella
Daily use of 1 mg estradiol and 0.5 mg norethindrone acetate administrated orally
Intervention: activella (Drug)
Outcomes
Primary Outcomes
Comparing the proportion of women with endometrial thickness not exceeding 8mm and change not exceeding 3mm between the two groups.
Time Frame: 1 year
Secondary Outcomes
- Comparison of the proportion of bleeding pattern between the two groups.(1 year)
- To demonstrate that vaginal progesterone tablets decrease systemic progesterone adverse reactions using a questionnaire.(1 year)