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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy & Tolerability of Progesterone Vaginal Tablets (Endometrin®) in Menopausal Women Treated by Estrogen Replacement Therapy - Phase II Comparative Study

Conditions
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Endometrial Hyperplasia, Endometrial Cancer

Intervention / Treatment
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* Drug: progesterone
* Drug: activella


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Progesterone vaginal tablet<br>Group A - Daily use of Endometrin 100 mg progesterone vaginal tablet, and Estrofem orally. | Drug: progesterone<br>* Daily use of 100 mg progesterone vaginal tablet, and Estrofem; estradiol 1 mg administrated orally. for 6 month<br>* Other names: Endometrin;|
| Other: Activella<br>Daily use of 1 mg estradiol and 0.5 mg norethindrone acetate administrated orally | Drug: activella<br>* Daily use of 1 mg estradiol and 0.5 mg norethindrone acetate administrated orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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menopause, Endometrial Thickness, progesterone