Endometrial Safety Study of a 0.5 mg Estradiol and 2.5 mg Dydrogesterone Combination

Study Overview
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Brief Summary
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The purpose of this study is to demonstrate endometrial safety of continuous combined 0.5 mg estradiol and 2.5 mg dydrogesterone.

Official Title
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Endometrial Safety of a Low Dose Continuous Combined 17 -Estradiol/Dydrogesterone Hormone Replacement Regimen (E2 0.5 mg/ D 2.5 mg) in Postmenopausal Women - A One-Year, Open Label, Multi-Center Study

Conditions
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Postmenopause

Intervention / Treatment
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* Drug: 0.5 Mg Estradiol and 2.5 Mg Dydrogesterone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Amenorrhoea for >= 12 months. Serum estradiol and FSH level within the postmenopausal range Baseline endometrial biopsy assessed by light microscopic histological evaluation revealing: insufficient endometrial tissue for diagnosis because of insufficient available (atrophic) endometrial tissue (not because of an inaccessible cervix) and endometrial thickness < 5 mm (double layer) by transvaginal ultrasound, atrophic endometrium, secretory endometrium, menstrual type endometrium, proliferative endometrium Exclusion Criteria: Previous systemic unopposed estrogen replacement therapy over 6 months or more. Any estrogen, progestogen, and/or androgen therapy in the last four weeks before Screening Visit (Visit 1). The baseline endometrial biopsy should in all cases be taken after cessation of the withdrawal bleeding due to previous hormone replacement therapy. History or presence of an estrogen dependent neoplasia (including breast- cancer). History or presence of malignant neoplasms other than basal or spinal cell carcinoma of the skin.

Ages Eligible for Study
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Minimum Age: 45 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: 0.5 Mg Estradiol and 2.5 Mg Dydrogesterone<br>* p.o. daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of endometrial hyperplasia or a more serious endometrial outcome during the 52 week treatment period |  | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days with bleeding/spotting; Number of bleeding/spotting episodes; Number of days with a certain bleeding intensity (e.g. bleeding intensity =2); |  | 52 weeks | 
| Length of bleeding free intervals; Amenorrhoea yes/no (absence of spotting and bleeding); Absence of bleeding yes/no; |  | 52 weeks | 
| QualiPause Inventory (domains: psychological, vasomotor, somatic, sexual, menstrual, androgenic): average score of the single items within the domain; QualiPause Inventory 7D: weighted sum score of the symptoms |  | 52 weeks |