ZK283197 for Treatment of Vasomotor Symptoms

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2008-12-31

Brief Summary

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The primary goal of the planned study is to investigate the efficacy and safety of ZK 283197 in the dosage of 2 and 3 mg ingested once daily during a period of 8 weeks for the treatment of hot flushes. In order to be able to assess the efficacy of the test substance, this is compared with the efficacy of 1 mg Estradiol and placebo. The comparator Estradiol is a certified hormone preparation, which is already used for the treatment of hot flushes as standard treatment. After passing the screening, volunteers will start with a run-in phase followed by a 8 weeks treatment and a follow-up phase. 112 postmenopausal women with hot flushes and without relevant prior diseases will participate in three European countries (2 study sites in Germany, 1 study site in Great Britain and 1 study site in The Netherlands) in this study.

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Detailed Description

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Conditions

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Vasomotor System

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ZK 283197, 3 mg

Postmenopausal women with hot flushes received 3 mg (3 x 1 mg tablets) ZK 283197, administered orally once daily over 8 weeks

Group Type EXPERIMENTAL

BAY 86-5310 (ZK 283197)

Intervention Type DRUG

3 mg (3 x 1 mg tablet) or 2 mg (2 x 1 mg tablet) ZK 283197 in respective treatment group, once daily p.o. over 8 weeks

Matching placebo

Postmenopausal women with hot flushes received placebo (3 tablets) orally once daily over 8 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo, once daily p.o. over 8 weeks

ZK 283197, 2 mg

Postmenopausal women with hot flushes received 2 mg (2 x 1 mg tablet) ZK 283197 plus 1 placebo tablet, once daily orally over 8 weeks

Group Type EXPERIMENTAL

BAY 86-5310 (ZK 283197)

Intervention Type DRUG

3 mg (3 x 1 mg tablet) or 2 mg (2 x 1 mg tablet) ZK 283197 in respective treatment group, once daily p.o. over 8 weeks

17ß-estradiol

Postmenopausal women with hot flushes received 1 mg (2 x 0.5 mg tablet) 17ß-estradiol plus 1 placebo tablet, once daily orally over 8 weeks

Group Type ACTIVE_COMPARATOR

17ß-estradiol

Intervention Type DRUG

1 mg (2 x 0.5 mg tablet) 17ß-estradiol, once daily p.o. over 8 weeks

Interventions

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BAY 86-5310 (ZK 283197)

3 mg (3 x 1 mg tablet) or 2 mg (2 x 1 mg tablet) ZK 283197 in respective treatment group, once daily p.o. over 8 weeks

Intervention Type DRUG

Placebo

Placebo, once daily p.o. over 8 weeks

Intervention Type DRUG

17ß-estradiol

1 mg (2 x 0.5 mg tablet) 17ß-estradiol, once daily p.o. over 8 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Women with at least 35 moderate to severe hot flushes in seven consecutive days
* Body mass index (BMI) : 20 - 30 kg/m² (inclusive)
* Postmenopausal status

Exclusion Criteria

* Contraindication for use for hormonal therapy
* Prior hysterectomy
* Hormonal therapy or intrauterine hormone releasing device within 4 weeks prior to study entry or any long-acting injectable or implant up to 6 months prior to study entry
* Repeated intake of medications affecting study aim

Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No