Clinical trial NCT00537836: ZK283197 for Treatment of Vasomotor Symptoms
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Vasomotor System
Keywords: Hot flushes
Therapy of hot flushes
17ß-estradiol (E2)
Hormone replacement therapy
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2007-10-01
Enrollment: 116
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Relative change in frequency of moderate to severe hot flushes per week between baseline and Week 8 of the treatment phase
timeFrame: Between baseline and Week 8 of the treatment phase
Secondary outcomes:
measure: Number of participants with adverse events
timeFrame: From Week 1 of treatment until end of Follow-up period (approximately 12 weeks)
measure: Exposure-response relationship
timeFrame: At week 8
measure: Change from baseline to all treatment weeks in frequency and severity of moderate to severe hot flushes
timeFrame: From baseline up to 8 weeks
measure: Change from baseline to all treatment weeks in severity and frequency of all hot flushes
timeFrame: From baseline up to 8 weeks
measure: Trough levels at every visit
timeFrame: Before 1st administration and at Week 1, 2, 4, 6 and 8
measure: AUC(0-24h)
timeFrame: Pre-dose and up to 24 h post-dose (measured between Week 4-8)
measure: Cmax
timeFrame: Pre-dose and up to 24 h post-dose (measured between Week 4-8)
measure: tmax
timeFrame: Pre-dose and up to 24 h post-dose (measured between Week 4-8)
measure: Cmin
timeFrame: Pre-dose and up to 24 h post-dose (measured between Week 4-8)
measure: Cave
timeFrame: Pre-dose and up to 24 h post-dose (measured between Week 4-8)
measure: Vaginal cytology
timeFrame: Between baseline and Week 8
measure: Endometrial thickness
timeFrame: Fom baseline to Week 8
measure: Endometrial histology
timeFrame: Between baseline and Week 8
Other outcomes:
Locations:
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Groningen
country: Netherlands
city: Cambridge
country: United Kingdom
state: Cambridgeshire
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: