A New Treatment Option for Heavy Menstrual Bleeding
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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)|
- • The primary efficacy end-point will be the proportion of women with a reduction ≥ 50% from baseline [ Time Frame: Baseline to outcome 12weeks ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Open label single group measuring the efficacy of a combined hormonal contraceptive to restore a normal level of MBL
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||August 2015|
|Estimated Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
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
Women will collect menstrual blood for 3 cycles and will be eligible to enter the treatment phase if in two of the three pre-treatment cycles the measured menstrual blood loss (MBL)is >80ml. The mean of these baseline MBL measurements will be the comparator for the efficacy treatment measurement. Iron studies (serum ferritin, Fe and transferrin) will also be measured pre and post treatment and related to women's assessment of their quality of life measured on a validated questionnaire.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01715025
|Contact: Edith Weisberg, MB BS MM||61 2 8752 firstname.lastname@example.org|
|Contact: Jane Hangan, RN||61 409 091 email@example.com|
|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|