A New Treatment Option for Heavy Menstrual Bleeding
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01715025|
Recruitment Status : Unknown
Verified November 2012 by Sydney Centre for Reproductive Health Research.
Recruitment status was: Recruiting
First Posted : October 26, 2012
Last Update Posted : November 19, 2014
Women with measured menstrual bleeding >80ml per cycle and no contraindications to combined oral contraceptive use will be assigned to an oestradiol/nomegestrol acetate oral contraceptive for 3 cycles during which they will collect all menstrual blood and send all used sanitary protection to the laboratory at the University of Sydney for estimation of blood loss by the alkaline haematin method.
An estradiol/nomogestrel acetate (E2/NOMAC) combined pill will be effective in controlling HMB in the majority of women without structural pelvic pathology.
The primary efficacy end-point will be the proportion of women with a reduction of menstrual blood loss ≥ 50% from baseline.
|Condition or disease||Intervention/treatment||Phase|
|Menorrhagia||Drug: E2Nomac||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-labeled Pilot Study to Determine the Efficacy of an E2//Nomegestrol Acetate (E2/NOMAC)Combination Oral Contraceptive (COC) in the Management of Heavy Menstrual Bleeding (HMB)|
|Study Start Date :||April 2013|
|Estimated Primary Completion Date :||April 2015|
|Estimated Study Completion Date :||August 2015|
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.
Women will start the first cycle of the COC on the first day of their period in the treatment phase of the study
Other Name: Zoely
- • The primary efficacy end-point will be the proportion of women with a reduction ≥ 50% from baseline [ Time Frame: Baseline to outcome 12weeks ]A single arm open label intervention study
- •• A secondary efficacy endpoint will be the number and proportion of cycles with a normal blood loss ≤ 80mls [ Time Frame: •Baseline to endpoint 12 weeks ]Open label single group measuring the efficacy of a combined hormonal contraceptive to restore a normal level of MBL
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01715025
|Contact: Edith Weisberg, MB BS MM||61 2 8752 email@example.com|
|Contact: Jane Hangan, RN||61 409 091 firstname.lastname@example.org|
|Australia, New South Wales|
|Sydney, New South Wales, Australia, 2131|
|Principal Investigator: Edith Weisberg, MB BS MM|
|Principal Investigator:||Edith Weisberg, MB BS MM||Sydney Centre for Reproductive Health Research FPNSW|