Vasomotor SystemPhase 2NCT00537836
ZK283197 for Treatment of Vasomotor Symptoms
A Phase 2 study testing BAY 86-5310 (ZK 283197) and 17ß-estradiol in people with Vasomotor System, run by Bayer at 4 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Vasomotor System
- What is being tested?
- BAY 86-5310 (ZK 283197) and 17ß-estradiol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Oct 2007to Dec 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Germany2 sites
Study site
Berlin, State of Berlin, 10115
Study site
Berlin, State of Berlin, 13353
About this study
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
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.
- Conditions
- Vasomotor System
- Being tested
- BAY 86-5310 (ZK 283197), Placebo, 17ß-estradiol
- Keywords
- Hot flushes, Therapy of hot flushes, 17ß-estradiol (E2), Hormone replacement therapy
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
PlaceboDrug
Placebo, once daily p.o. over 8 weeks
17ß-estradiolDrug
1 mg (2 x 0.5 mg tablet) 17ß-estradiol, once daily p.o. over 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| ZK 283197, 3 mg | Experimental | Postmenopausal women with hot flushes received 3 mg (3 x 1 mg tablets) ZK 283197, administered orally once daily over 8 weeks Receives: Drug: BAY 86-5310 (ZK 283197) |
| Matching placebo | Placebo comparator | Postmenopausal women with hot flushes received placebo (3 tablets) orally once daily over 8 weeks Receives: Drug: Placebo |
| ZK 283197, 2 mg | Experimental | 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 Receives: Drug: BAY 86-5310 (ZK 283197) |
| 17ß-estradiol | Active comparator | 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 Receives: Drug: 17ß-estradiol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative change in frequency of moderate to severe hot flushes per week between baseline and Week 8 of the treatment phase
Measured: Between baseline and Week 8 of the treatment phase
Secondary outcomes (13)
Number of participants with adverse events
Measured: From Week 1 of treatment until end of Follow-up period (approximately 12 weeks)
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
Measured: At week 8
Change from baseline to all treatment weeks in frequency and severity of moderate to severe hot flushes
Measured: From baseline up to 8 weeks
Change from baseline to all treatment weeks in severity and frequency of all hot flushes
Measured: From baseline up to 8 weeks
Trough levels at every visit
Measured: Before 1st administration and at Week 1, 2, 4, 6 and 8
AUC(0-24h)
Area under the curve from administration to 24 h after administration
Measured: Pre-dose and up to 24 h post-dose (measured between Week 4-8)
Cmax
Maximum serum concentration
Measured: Pre-dose and up to 24 h post-dose (measured between Week 4-8)
tmax
Time to reach maximum drug concentration
Measured: Pre-dose and up to 24 h post-dose (measured between Week 4-8)
Cmin
Minimum serum concentration
Measured: Pre-dose and up to 24 h post-dose (measured between Week 4-8)
Cave
Average serum concentration
Measured: Pre-dose and up to 24 h post-dose (measured between Week 4-8)
Vaginal cytology
The epithelial maturation index/value and the karyopycnotic index were assessed
Measured: Between baseline and Week 8
Endometrial thickness
Transvaginal ultrasound was performed to demonstrate the absence of relevant endometrium growth
Measured: Fom baseline to Week 8
Endometrial histology
Measured: Between baseline and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2007 (estimated)
- Study startOct 2007
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vasomotor SystemStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00537836
- Sponsor's protocol ID
- 91544
- Other IDs
- 2007-001791-36, 310781
- Status last verified
- Apr 2015
- First submitted
- 28 Sep 2007
- Last updated
- 9 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00537836
- Acronym / sponsor ID
- 91544
- Conditions
- Vasomotor System
- Keywords
- Hot flushes, Therapy of hot flushes, 17ß-estradiol (E2), Hormone replacement therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 1 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ZK 283197, 3 mg | Experimental | Drug: BAY 86-5310 (ZK 283197)Postmenopausal women with hot flushes received 3 mg (3 x 1 mg tablets) ZK 283197, administered orally once daily over 8 weeks |
| Matching placebo | Placebo comparator | Drug: PlaceboPostmenopausal women with hot flushes received placebo (3 tablets) orally once daily over 8 weeks |
| ZK 283197, 2 mg | Experimental | Drug: BAY 86-5310 (ZK 283197)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 |
| 17ß-estradiol | Active comparator | Drug: 17ß-estradiolPostmenopausal 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 |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | ZK 283197, 2 mg, ZK 283197, 3 mg |
| PlaceboPlacebo, once daily p.o. over 8 weeks | Drug | Matching placebo |
| 17ß-estradiol1 mg (2 x 0.5 mg tablet) 17ß-estradiol, once daily p.o. over 8 weeks | Drug | 17ß-estradiol |
Primary outcome
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
13 secondary outcomes
Number of participants with adverse events
Time frame: From Week 1 of treatment until end of Follow-up period (approximately 12 weeks)
Exposure-response relationship
Time frame: At week 8
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
Change from baseline to all treatment weeks in severity and frequency of all hot flushes
Time frame: From baseline up to 8 weeks
Trough levels at every visit
Time frame: Before 1st administration and at Week 1, 2, 4, 6 and 8
AUC(0-24h)
Time frame: Pre-dose and up to 24 h post-dose (measured between Week 4-8)
Cmax
Time frame: Pre-dose and up to 24 h post-dose (measured between Week 4-8)
tmax
Time frame: Pre-dose and up to 24 h post-dose (measured between Week 4-8)
Cmin
Time frame: Pre-dose and up to 24 h post-dose (measured between Week 4-8)
Cave
Time frame: Pre-dose and up to 24 h post-dose (measured between Week 4-8)
Vaginal cytology
Time frame: Between baseline and Week 8
Endometrial thickness
Time frame: Fom baseline to Week 8
Endometrial histology
Time frame: Between baseline and Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2015.
- Click here to find information about studies related to Bayer Healthcare products conducted in EuropeLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BAY 86-5310 (ZK 283197) and 17ß-estradiol in people with Vasomotor System, run by Bayer at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, Netherlands, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2015.