Vasomotoric Symptoms Study of a 0.5 mg Estradiol and 2.5 mg Dydrogesterone Combination

Phase 3

Completed

• Conditions: Postmenopause
• Interventions: Drug: continuous combined estradiol and dydrogesterone; Drug: Placebo

• Registration Number: NCT00251082
• Lead Sponsor: Solvay Pharmaceuticals

Brief Summary

To demonstrate efficacy of continuous combined 0.5 mg estradiol and 2.5 mg dydrogesterone versus placebo in the treatment of vasomotor symptoms after a treatment period of 3 months and to investigate the bleeding pattern over a treatment period of one year

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-11-08
• Study First Submitted QC: 2005-11-08
• Study First Posted: 2005-11-09
• Study Start: 2005-12
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Status Verified: 2008-03
• Last Update Submitted: 2008-03-11
• Last Update Posted: 2008-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 391

Inclusion Criteria

• Non-hysterectomised postmenopausal women
• Amenorrhoea for >= 12 months
• Serum estradiol and follicle stimulating hormone (FSH) in the postmenopausal range

Exclusion Criteria

• Known hypersensitivity to estradiol, dydrogesterone or any of the excipients of the study medication
• Baseline endometrial biopsy result other than described in the inclusion criteria (no endometrial tissue for diagnosis, hyperplasia, carcinoma).
• Insufficient endometrial tissue for diagnosis obtained at baseline biopsy and endometrial thickness >= 5 mm (double layer) by transvaginal ultrasound.
• The presence of an endometrial polyp at baseline.
• Abnormal (un-investigated and/or unexplained) vaginal bleeding in the last 12 months prior to Screening Visit (Visit 1).
• Estradiol pellet/implant therapy during the past 6 months.
• Previous systemic unopposed estrogen replacement therapy over 6 months or more.
• History or presence of malignant neoplasms other than basal or spinal cell carcinoma of the skin

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	continuous combined estradiol and dydrogesterone	-
C	Placebo	-
B	continuous combined estradiol and dydrogesterone	-

Primary Outcome Measures

Name	Time	Method
The change in the number of moderate to severe hot flushes from baseline to week 13	12 weeks

Secondary Outcome Measures

Name	Time	Method
Change in the Menopause Rating Scale from baseline to weeks 4 and 13;	52 weeks
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 7D: weighted sum score of the symptoms	52 weeks
Change in the number of hot flushes from baseline to week 13; Change in the number of hot flushes and moderate to severe hot flushes from baseline to weeks 4 and 8;	12 weeks

Trial Locations

Locations (18)

Site 33; 🇵🇱 Kraków, Poland

Site 23; 🇫🇷 Cannes, France

Site 21; 🇫🇷 Montpellier, France

Site 12; 🇭🇷 Zagreb, Croatia

Site 53; 🇷🇺 Moscow, Russian Federation

Site 43; 🇷🇴 Craiova, Jud.Dolj, Romania

Site 31; 🇵🇱 Warszawa, Poland

Site 41; 🇷🇴 Bucharest, Romania

Site 42; 🇷🇴 Bucharest, Romania

Site 44; 🇷🇴 Bucharest, Romania

Site 11; 🇭🇷 Zagreb, Croatia

Site 13; 🇭🇷 Zagreb, Croatia

Site 34; 🇵🇱 Katowice, Poland

Site 32; 🇵🇱 Lódź, Poland

Site 24; 🇫🇷 Cannes, France

Site 51; 🇷🇺 Moscow, Russian Federation

Site 52; 🇷🇺 Moscow, Russian Federation

Site 22; 🇫🇷 Montpellier, France