ZK283197 for Treatment of Vasomotor Symptoms

Bayer

Status and phase: Completed; Phase 2

Conditions: Vasomotor System

Treatments: Drug: 17ß-estradiol; Drug: Placebo; Drug: BAY 86-5310 (ZK 283197)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00537836

310781 (Other Identifier)

2007-001791-36 (EudraCT Number)

91544

Details and patient eligibility

About

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.

Enrollment: 116 patients

Sex: Female

Ages: 45 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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116 participants in 4 patient groups, including a placebo group

ZK 283197, 3 mg

Experimental group

Description:

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

Treatment:

Drug: BAY 86-5310 (ZK 283197)

Matching placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

ZK 283197, 2 mg

Experimental group

Description:

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

Treatment:

Drug: BAY 86-5310 (ZK 283197)

17ß-estradiol

Active Comparator group

Description:

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

Treatment:

Drug: 17ß-estradiol