Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE4
30 participants
INTERVENTIONAL
2013-04-30
2015-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Hypothesis:
An estradiol/nomogestrel acetate (E2/NOMAC) combined pill will be effective in controlling HMB in the majority of women without structural pelvic pathology.
Main outcome:
The primary efficacy end-point will be the proportion of women with a reduction of menstrual blood loss ≥ 50% from baseline.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
E2/Nomac
Women with demonstrated HMB at baseline will be assigned to 3 cycles of a E2/Nomac combined pill 1 daily for 24 days followed by 1 placebo pill daily for 4 days per cycle.
E2Nomac
Women will start the first cycle of the COC on the first day of their period in the treatment phase of the study
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
E2Nomac
Women will start the first cycle of the COC on the first day of their period in the treatment phase of the study
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Women willing to collect all sanitary protection for 6 cycles
* Women with no contraindications to use of combined hormonal contraception
* Women not using any hormonal contraception or any treatment for HMB
* Women who have no demonstrable uterine pathology on pelvic ultrasound
* Women who have demonstrated a menstrual blood loss (MBL) \>80mls in 2 of 3 menstrual periods during the pre-treatment phase will be eligible to enter the treatment phase
Exclusion Criteria
* Women unwilling to collect all sanitary protection for 6 cycles
* Women using hormonal contraception or any treatment for HMB
* Women who have demonstrable uterine pathology on pelvic ultrasound
* Women who have demonstrated a MBL ≤80mls in 2 of 3 consecutive menstrual periods
18 Years
50 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Merck Sharp & Dohme LLC
INDUSTRY
Sydney Centre for Reproductive Health Research
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Edith Weisberg, MB BS MM
Role: PRINCIPAL_INVESTIGATOR
Sydney Centre for Reproductive Health Research FPNSW
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
SCRHR
Sydney, New South Wales, Australia
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
Fraser IS, Romer T, Parke S, Zeun S, Mellinger U, Machlitt A, Jensen JT. Effective treatment of heavy and/or prolonged menstrual bleeding with an oral contraceptive containing estradiol valerate and dienogest: a randomized, double-blind Phase III trial. Hum Reprod. 2011 Oct;26(10):2698-708. doi: 10.1093/humrep/der224. Epub 2011 Jul 21.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
R2012-7
Identifier Type: -
Identifier Source: org_study_id