Moderate to Severe Vasomotor Symptoms in PostmenopausalPhase 2NCT01015677
A Study of MK-6913 for the Treatment of Hot Flashes in Postmenopausal Women (6913-004)
A Phase 2 study testing MK-6913, 17-β estradiol and MK-6913 25 mg in people with Moderate to Severe Vasomotor Symptoms in Postmenopausal and Women, run by Merck Sharp & Dohme LLC.
Trial summary
This study will assess the safety, tolerability, and efficacy of MK-6913 for the treatment of moderate-to-very-severe vasomotor symptoms (hot flashes or hot flushes) in postmenopausal women. Read more about this study
- Who is it for?
- Ages 35 to 60 years, women only
- Conditions the study is for
- Moderate to Severe Vasomotor Symptoms in Postmenopausal, Women
- What is being tested?
- MK-6913, 17-β estradiol and MK-6913 25 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- No sites listed yet
- Study dates
- 17 Dec 2009to 30 Jul 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 35 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Woman with at least 50 moderate to very severe hot flash episodes per week
- Postmenopausal
- Between 45 and 60 years of age if naturally menopausal, or between 35 and 60 if she underwent a bilateral oophorectomy
- Not receiving hormone therapy
- Has had both a normal mammogram and a normal Pap test in the past 6 months
- Generally healthy
Who cannot join
- A history of cancer, except for certain skin cancers
- Undiagnosed vaginal bleeding or any uterine endometrial disorder
- Currently uses tobacco products, or has used them in the last 6 months
- Has human immunodeficiency virus (HIV)
About this study
Official title: A Phase IIa, Randomized, Double-Blind, Placebo- and Active-Controlled Study to Examine MK-6913 for the Treatment of Vasomotor Symptoms in Postmenopausal Women
This study will assess the safety, tolerability, and efficacy of MK-6913 for the treatment of moderate-to-very-severe vasomotor symptoms (hot flashes or hot flushes) in postmenopausal women. The primary study hypothesis is that one or more doses of MK-6913 will result in a significantly greater reduction from baseline, compared to placebo, in the number of moderate to very severe hot flashes after 4 weeks of treatment.
- Being tested
- MK-6913, 17-β estradiol, Placebo to MK-6913, Placebo to 17-β estradiol, MK-6913 25 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-6913Drug
17-β estradiolDrug
Placebo to MK-6913Drug
Placebo to 17-β estradiolDrug
MK-6913 25 mgDrug
| Study group | Role | What they receive |
|---|---|---|
| MK-6913 75 mg | Experimental | MK-6913 75 mg capsule and matching placebo for 17β-estradiol 1 mg tablet once daily for 4 weeks (Stage 1 and Stage 2) Receives: Drug: MK-6913; Drug: Placebo to 17-β estradiol |
| 17-β estradiol 1 mg | Active comparator | 17β-estradiol 1 mg tablet and matching placebo for MK-6913 75 mg capsule once daily for 4 weeks (Stage 1 and Stage 2) Receives: Drug: 17-β estradiol; Drug: Placebo to MK-6913 |
| Placebo | Placebo comparator | Matching placebo for MK-6913 75 mg capsule and matching placebo for 17β-estradiol 1 mg tablet once daily for 4 weeks (Stage 1 and State 2) Receives: Drug: Placebo to MK-6913; Drug: Placebo to 17-β estradiol |
| MK-6913 25 mg | Experimental | MK-6913 25 mg capsule and matching placebo for 17β-estradiol 1 mg tablet once daily for 4 weeks (Stage 2) Receives: Drug: MK-6913 25 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in the Number of Weekly Moderate to Very Severe Hot Flashes (Excluding Outliers) at Week 4
Hot flashes were recorded in real time and hot flashes recorded retrospectively in the morning and evening reports in a diary day via the Hot Flash e-diary were summed to determine the total number of hot flashes over a diary day. The total number of weekly moderate or worse hot flashes were calculated as the sum of the total number of hot flashes that occur over a diary week (non-missing diary day), divided by the number of days of diary completion, and multiplied by 7 (standardized week). At least 4 non-missing diary days were required to define the total number of weekly moderate or worse hot flashes. Hot flash data was excluded for participants whose number of moderate to severe hot flashes per week were in the top 1% of number of hot flashes reported to exclude any outlier effect.
Measured: Baseline and Week 4
Number of Participants Who Experienced at Least One or More Adverse Events (AE)
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Measured: Up to 6 weeks
Number of Participants Who Discontinued Study Drug Due to an AE
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Measured: Up to 4 weeks
Secondary outcomes (2)
Percent Change From Baseline in the Weekly Hot Flash Severity Score (Combining Severe and Very Severe Score) at Week 4
Hot flash severity score is calculated by the sum of: the number of mild hot flashes, 2 times number of moderate hot flashes, 3 times the number of severe hot flashes, and 4 times the number of very severe hot flashes. This sum was standardized to a 7-day week if there were any missing days in the e-diary. The severity of each hot flash was recorded by the Hot Flash e-diary.
Measured: Baseline and Week 4
Change From Baseline in Follicle-stimulating Hormone (FSH) Level at Week 4
FSH was measured to assess estrogen receptor (ER) selectivity (a biomarker for ERα activity and a pharmacodynamic endpoint).
Measured: Baseline and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2009 (estimated)
- Study start17 Dec 2009
- Primary completion30 Jul 2010
- Study completion30 Jul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Moderate to Severe Vasomotor Symptoms in PostmenopausalStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01015677
- Sponsor's protocol ID
- 6913-004
- Other IDs
- MK-6913-004
- Status last verified
- Aug 2018
- First submitted
- 17 Nov 2009
- Last updated
- 31 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa, Randomized, Double-Blind, Placebo- and Active-Controlled Study to Examine MK-6913 for the Treatment of Vasomotor Symptoms in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT01015677
- Acronym / sponsor ID
- 6913-004
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 17 Dec 2009 (actual)
- Primary completion
- 30 Jul 2010 (actual)
- Study completion
- 30 Jul 2010 (actual)
- First posted
- 18 Nov 2009 (estimated)
- Results
- Posted 4 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the safety, tolerability, and efficacy of MK-6913 for the treatment of moderate-to-very-severe vasomotor symptoms (hot flashes or hot flushes) in postmenopausal women. The primary study hypothesis is that one or more doses of MK-6913 will result in a significantly greater reduction from baseline, compared to placebo, in the number of moderate to very severe hot flashes after 4 weeks of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MK-6913 75 mg | Experimental | Drug: MK-6913, Drug: Placebo to 17-β estradiolMK-6913 75 mg capsule and matching placebo for 17β-estradiol 1 mg tablet once daily for 4 weeks (Stage 1 and Stage 2) |
| 17-β estradiol 1 mg | Active comparator | Drug: 17-β estradiol, Drug: Placebo to MK-691317β-estradiol 1 mg tablet and matching placebo for MK-6913 75 mg capsule once daily for 4 weeks (Stage 1 and Stage 2) |
| Placebo | Placebo comparator | Drug: Placebo to MK-6913, Drug: Placebo to 17-β estradiolMatching placebo for MK-6913 75 mg capsule and matching placebo for 17β-estradiol 1 mg tablet once daily for 4 weeks (Stage 1 and State 2) |
| MK-6913 25 mg | Experimental | Drug: MK-6913 25 mgMK-6913 25 mg capsule and matching placebo for 17β-estradiol 1 mg tablet once daily for 4 weeks (Stage 2) |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Woman with at least 50 moderate to very severe hot flash episodes per week
- Postmenopausal
- Between 45 and 60 years of age if naturally menopausal, or between 35 and 60 if she underwent a bilateral oophorectomy
- Not receiving hormone therapy
- Has had both a normal mammogram and a normal Pap test in the past 6 months
Key exclusion criteria (4 listed)
- A history of cancer, except for certain skin cancers
- Undiagnosed vaginal bleeding or any uterine endometrial disorder
- Currently uses tobacco products, or has used them in the last 6 months
- Has human immunodeficiency virus (HIV)
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 |
|---|---|---|
| MK-6913 | Drug | MK-6913 75 mg |
| 17-β estradiol | Drug | 17-β estradiol 1 mg |
| Placebo to MK-6913 | Drug | 17-β estradiol 1 mg, Placebo |
| Placebo to 17-β estradiol | Drug | MK-6913 75 mg, Placebo |
| MK-6913 25 mg | Drug | MK-6913 25 mg |
Primary outcome
Percent Change From Baseline in the Number of Weekly Moderate to Very Severe Hot Flashes (Excluding Outliers) at Week 4
Time frame: Baseline and Week 4
Hot flashes were recorded in real time and hot flashes recorded retrospectively in the morning and evening reports in a diary day via the Hot Flash e-diary were summed to determine the total number of hot flashes over a diary day. The total number of weekly moderate or worse hot flashes were calculated as the sum of the total number of hot flashes that occur over a diary week (non-missing diary day), divided by the number of days of diary completion, and multiplied by 7 (standardized week). At least 4 non-missing diary days were required to define the total number of weekly moderate or worse hot flashes. Hot flash data was excluded for participants whose number of moderate to severe hot flashes per week were in the top 1% of number of hot flashes reported to exclude any outlier effect.
Number of Participants Who Experienced at Least One or More Adverse Events (AE)
Time frame: Up to 6 weeks
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Number of Participants Who Discontinued Study Drug Due to an AE
Time frame: Up to 4 weeks
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
2 secondary outcomes
Percent Change From Baseline in the Weekly Hot Flash Severity Score (Combining Severe and Very Severe Score) at Week 4
Time frame: Baseline and Week 4
Change From Baseline in Follicle-stimulating Hormone (FSH) Level at Week 4
Time frame: Baseline and Week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
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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.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MK-6913, 17-β estradiol and MK-6913 25 mg in people with Moderate to Severe Vasomotor Symptoms in Postmenopausal and Women, run by Merck Sharp & Dohme LLC.
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 6 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: stopped early, as of the sponsor's last update on 31 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 4 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent Change From Baseline in the Number of Weekly Moderate to Very Severe Hot Flashes (Excluding Outliers) at Week 4 (time frame: Baseline and Week 4). The study lists 3 primary outcomes in all. 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 31 Aug 2018.