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.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

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.

Conditions: Moderate to Severe Vasomotor Symptoms in Postmenopausal, Women
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 groups in NCT01015677
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.

17 Dec 200930 Jul 2010

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)

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
Conditions: Moderate to Severe Vasomotor Symptoms in Postmenopausal, Women
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.

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

Results posted to the registry on 4 May 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MK-6913 75 mg	34	33
17-β Estradiol 1 mg	32	28
Placebo	33	33

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. Least squares mean (95% Confidence Interval). Unit: Percent change

Measure	MK-6913 75 mg n = 34	17-β Estradiol 1 mg n = 31	Placebo n = 33
Value	-40.69 (-54.82 to -26.56)	-51.86 (-66.38 to -37.34)	-34.41 (-48.99 to -19.83)

MK-6913 75 mg vs Placebo: Differrence in the least squares means: -6.28 (95% CI -24.20 to 11.64), p = 0.488, Longitudinal Data Analysis (LDA)
17-β Estradiol 1 mg vs Placebo: Difference in the least squares means: -17.45 (95% CI -36.28 to 1.38), p = 0.069, Longitudinal Data Analysis

Population analysed: The Full Analysis Set (FAS) population consists of all randomized participants who receive at least 1 dose of study treatment, have at least 1 post-randomization observation for the analysis endpoint, and have baseline data for those analyses.

Primary outcome: Number of Participants Who Experienced at Least One or More Adverse Events (AE)

Time frame: Up to 6 weeks. Number. Unit: Participants

Measure	MK-6913 75 mg n = 34	17-β Estradiol 1 mg n = 32	Placebo n = 33
Value	17	15	16

Population analysed: The All-Patients-as Treated (APaT) population is all participants who received at least one dose of study drug.

Primary outcome: Number of Participants Who Discontinued Study Drug Due to an AE

Time frame: Up to 4 weeks. Number. Unit: Participants

Measure	MK-6913 75 mg n = 34	17-β Estradiol 1 mg n = 32	Placebo n = 33
Value	0	1	0

Population analysed: The APaT population is all participants who received at least one dose of study drug.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 6 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MK-6913 75 mg	0 of 34 (0%)	17 of 34 (50%)	Not reported
17-β Estradiol 1 mg	0 of 32 (0%)	15 of 32 (46.9%)	Not reported
Placebo	0 of 33 (0%)	16 of 33 (48.5%)	Not reported

Limitations and caveats (from the sponsor): The study was terminated at the end of Stage 1 so no participants entered Stage 2 and no participants received MK-6913 25 mg.

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

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?

On the ClinicalTrials.gov record for NCT01015677.

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; AzTrials last refreshed its copy on 8 Nov 2026.