Overview

A New Treatment Option for Heavy Menstrual Bleeding

Status:
Unknown status
Trial end date:
2015-08-01
Target enrollment:
Participant gender:
Summary
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. 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.
Phase:
Phase 4
Details
Lead Sponsor:
Sydney Centre for Reproductive Health Research
Collaborator:
Merck Sharp & Dohme Corp.
Treatments:
Contraceptive Agents
Contraceptives, Oral