Endometrial Safety Study

Study Overview
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Brief Summary
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The study is designed to investigate the safety of the investigational product for the lining of the uterus (endometrium).

Official Title
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A Double-blind, Randomized, Multi-center Study to Investigate the Endometrial Safety of a Continuous, Combined, Oral Estrogen/Progestin Preparation (17b-estradiol [E2] / Drospirenone [DRSP]) and to Compare the Bleeding Pattern of Subjects Treated With E2 / DRSP With the Bleeding Pattern of Subjects Treated With E2 / Norethisterone Acetate (NETA) When Used for Hormone Therapy (HT) for 1 Year in Post-menopausal Women

Conditions
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Postmenopause

Intervention / Treatment
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* Drug: 0.25mg DRSP / 0.5mg E2 (BAY86-4891)
* Drug: 0.5mg NETA / 1.0mg E2 (Activella)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Postmenopausal women between 40 and 65 years of age with hormone therapy indication (symptoms and need for treatment) Non-hysterectomized women. Exclusion Criteria: Usual exclusion criteria for hormone therapy apply.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.25mg DRSP / 0.5mg E2 (BAY86-4891)<br>One capsule [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 13 cycles (28 days per cycle). | Drug: 0.25mg DRSP / 0.5mg E2 (BAY86-4891)<br>* One capsule [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 13 cycles (28 days per cycle).<br>|
| Active Comparator: 0.5mg NETA / 1.0mg E2 (Activella)<br>One capsule [0.5mg norethisterone acetate/1.0mg 17β-estradiol (NETA/E2)] per day taken orally for 13 cycles (28 days per cycle). | Drug: 0.5mg NETA / 1.0mg E2 (Activella)<br>* One capsule [0.5mg norethisterone acetate/1.0mg 17β-estradiol (NETA/E2)] per day taken orally for 13 cycles (28 days per cycle).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants in the DRSP/E2 Group With an Assessment of Endometrial Hyperplasia or Worse at End of Study (EoS) (1 Year of Treatment) | The number of women who had a biopsy classified as 'hyperplasia or worse' at any time during the study. According to the protocol this endpoint was defined as primary for the DRSP/E2 group only. | Up to one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Amenorrhea During Month 1 to 3 of Treatment | The women were to record daily in a diary, indicating 'no bleeding', 'spotting', 'light bleeding', 'normal bleeding' or 'heavy bleeding'. Women were considered to have amenorrhea if they had no bleeding and no spotting day within the given time interval. | Month 1 to Month 3 | 
| Number of Participants With Amenorrhea During Month 10 to 12 of Treatment | The women were to record any bleeding daily in a diary, indicating 'no bleeding', 'spotting', 'light bleeding', 'normal bleeding' or 'heavy bleeding'. Women were considered to have amenorrhea if they had no bleeding and no spotting day within the given time interval. | Month 10 to Month 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postmenopausal Symptoms e.g., Hot flushes, Sweating episodes, Vaginal dryness