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Completed

NCT Number: NCT00537836

ZK283197 for Treatment of Vasomotor Symptoms

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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Key information

Conditions

Vasomotor System Hot Flashes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

45 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Berlin, State of Berlin, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BAY 86-5310 (ZK 283197)

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

Placebo

Drug

Placebo, once daily p.o. over 8 weeks

17ß-estradiol

Drug

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

Primary outcomes

  1. Relative change in frequency of moderate to severe hot flushes per week between baseline and Week 8 of the treatment phase

    Time frame: Between baseline and Week 8 of the treatment phase

Secondary outcomes

  1. Number of participants with adverse events

    Time frame: From Week 1 of treatment until end of Follow-up period (approximately 12 weeks)

  2. Exposure-response relationship

    Time frame: At week 8

    A generalized linear model was applied to explore the dependence of the number of hot flushes in Week 8 to (i) the dose of ZK 283197, (ii) the AUC of ZK 283197, (iii) the maximum concentration Cmax of ZK 283197 and (iv) the average concentration Cave of ZK 283197

  3. Change from baseline to all treatment weeks in frequency and severity of moderate to severe hot flushes

    Time frame: From baseline up to 8 weeks

  4. Change from baseline to all treatment weeks in severity and frequency of all hot flushes

    Time frame: From baseline up to 8 weeks

  5. Trough levels at every visit

    Time frame: Before 1st administration and at Week 1, 2, 4, 6 and 8

  6. AUC(0-24h)

    Time frame: Pre-dose and up to 24 h post-dose (measured between Week 4-8)

    Area under the curve from administration to 24 h after administration

  7. Cmax

    Time frame: Pre-dose and up to 24 h post-dose (measured between Week 4-8)

    Maximum serum concentration

  8. tmax

    Time frame: Pre-dose and up to 24 h post-dose (measured between Week 4-8)

    Time to reach maximum drug concentration

  9. Cmin

    Time frame: Pre-dose and up to 24 h post-dose (measured between Week 4-8)

    Minimum serum concentration

  10. Cave

    Time frame: Pre-dose and up to 24 h post-dose (measured between Week 4-8)

    Average serum concentration

  11. Vaginal cytology

    Time frame: Between baseline and Week 8

    The epithelial maturation index/value and the karyopycnotic index were assessed

  12. Endometrial thickness

    Time frame: Fom baseline to Week 8

    Transvaginal ultrasound was performed to demonstrate the absence of relevant endometrium growth

  13. Endometrial histology

    Time frame: Between baseline and Week 8

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

A Double-blind, Randomized, Placebo and Active Controlled, Multicenter Study to Investigate Efficacy and Safety After Oral Administration of 2 and 3 mg ZK 283197, 1 mg 17ß-estradiol and Placebo Once Daily for 8 Weeks in Postmenopausal Women With Hot Flushes

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Oct 1, 2007
Registry last updated
Apr 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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