Vasomotor System Clinical Trial
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
| Verified date | April 2015 |
| Source | Bayer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Germany: Federal Institute for Drugs and Medical Devices |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 116 |
| Est. completion date | December 2008 |
| Est. primary completion date | December 2008 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 45 Years to 65 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Bayer |
Germany, Netherlands, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Relative change in frequency of moderate to severe hot flushes per week between baseline and Week 8 of the treatment phase | Between baseline and Week 8 of the treatment phase | No | |
| Secondary | Number of participants with adverse events | From Week 1 of treatment until end of Follow-up period (approximately 12 weeks) | Yes | |
| Secondary | Exposure-response relationship | 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 | At week 8 | No |
| Secondary | Change from baseline to all treatment weeks in frequency and severity of moderate to severe hot flushes | From baseline up to 8 weeks | No | |
| Secondary | Change from baseline to all treatment weeks in severity and frequency of all hot flushes | From baseline up to 8 weeks | No | |
| Secondary | Trough levels at every visit | Before 1st administration and at Week 1, 2, 4, 6 and 8 | No | |
| Secondary | AUC(0-24h) | Area under the curve from administration to 24 h after administration | Pre-dose and up to 24 h post-dose (measured between Week 4-8) | No |
| Secondary | Cmax | Maximum serum concentration | Pre-dose and up to 24 h post-dose (measured between Week 4-8) | No |
| Secondary | tmax | Time to reach maximum drug concentration | Pre-dose and up to 24 h post-dose (measured between Week 4-8) | No |
| Secondary | Cmin | Minimum serum concentration | Pre-dose and up to 24 h post-dose (measured between Week 4-8) | No |
| Secondary | Cave | Average serum concentration | Pre-dose and up to 24 h post-dose (measured between Week 4-8) | No |
| Secondary | Vaginal cytology | The epithelial maturation index/value and the karyopycnotic index were assessed | Between baseline and Week 8 | Yes |
| Secondary | Endometrial thickness | Transvaginal ultrasound was performed to demonstrate the absence of relevant endometrium growth | Fom baseline to Week 8 | Yes |
| Secondary | Endometrial histology | Between baseline and Week 8 | Yes |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00369434 -
Study of the Safety and Efficacy of Desvenlafaxine Succinate for Vasomotor Symptoms in Postmenopausal Women
|
Phase 3 |