Efficacy and Tolerability Study of Progesterone Vaginal Tablets (Endometrin®) in Menopausal Women Treated by Estrogen

Phase 2

• Conditions: Endometrial Hyperplasia; Endometrial Cancer
• Interventions: Drug: activella; Drug: progesterone

• Registration Number: NCT00919919
• Lead Sponsor: Rabin Medical Center

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 Timeline

• Status Verified: 2009-06
• Study Start: 2009-06
• Study First Submitted: 2009-06-09
• Study First Submitted QC: 2009-06-11
• Last Update Submitted: 2009-06-11
• Study First Posted: 2009-06-12
• Last Update Posted: 2009-06-12
• Primary Completion: 2010-09
• Study Completion: 2010-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Activella	activella	Daily use of 1 mg estradiol and 0.5 mg norethindrone acetate administrated orally
Progesterone vaginal tablet	progesterone	Group A - Daily use of Endometrin 100 mg progesterone vaginal tablet, and Estrofem orally.

Primary Outcome Measures

Name	Time	Method
Comparing the proportion of women with endometrial thickness not exceeding 8mm and change not exceeding 3mm between the two groups.	1 year

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Rabin Medical Center Beilinson Hospital; 🇮🇱 Petach Tikva, Israel