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A New Treatment Option for Heavy Menstrual Bleeding

NCT01715025 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2014-11-19

No results posted yet for this study

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.

Conditions

  • Menorrhagia

Interventions

DRUG

E2Nomac

Women will start the first cycle of the COC on the first day of their period in the treatment phase of the study

Sponsors & Collaborators

Principal Investigators

  • Edith Weisberg, MB BS MM · Sydney Centre for Reproductive Health Research FPNSW

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2015-04-30
Completion
2015-08-31

Countries

  • Australia

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01715025 on ClinicalTrials.gov