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

Phase 3

Completed

• Conditions: Postmenopause
• Interventions: Drug: 0.5 Mg Estradiol and 2.5 Mg Dydrogesterone

• Registration Number: NCT00160316
• Lead Sponsor: Solvay Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-12
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2008-03
• Last Update Submitted: 2008-03-11
• Last Update Posted: 2008-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 454

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	0.5 Mg Estradiol and 2.5 Mg Dydrogesterone	-

Primary Outcome Measures

Name	Time	Method
Presence of endometrial hyperplasia or a more serious endometrial outcome during the 52 week treatment period	52 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (22)

Site 42; 🇷🇴 Bucharest, Romania

Site 43; 🇷🇴 Bucharest, Romania

Site 44; 🇷🇴 Bucharest, Romania

Site 45; 🇷🇴 Bucharest, Romania

Site 20; 🇺🇦 Kiev, Ukraine

Site 24; 🇺🇦 Donetsk, Ukraine

Site 23; 🇺🇦 Zaporozhye, Ukraine

Site 12; 🇭🇷 Zagreb, Croatia

Site 36; 🇵🇱 Kraków, Poland

Site 40; 🇷🇴 Bucharest, Romania

Site 11; 🇭🇷 Zagreb, Croatia

Site 30; 🇵🇱 Kraków, Poland

Site 34; 🇵🇱 Lublin, Poland

Site 35; 🇵🇱 Kraków, Poland

Site 33; 🇵🇱 Warszawa, Poland

Site 10; 🇭🇷 Zagreb, Croatia

Site 32; 🇵🇱 Katowice, Poland

Site 21; 🇺🇦 Kiev, Ukraine

Site 31; 🇵🇱 Miechów, Poland

Site 41; 🇷🇴 Bucharest, Romania

Site 13; 🇭🇷 Zagreb, Croatia

Site 22; 🇺🇦 Kiev, Ukraine