A New Treatment Option for Heavy Menstrual Bleeding

Menorrhagia Clinical Trial

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)

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01715025
• Other study ID #: R2012-7
• Status: Unknown status
• Phase: Phase 4
• First received: October 23, 2012
• Last updated: November 17, 2014
• Start date: April 2013
• Est. completion date: August 2015

Study information

• Verified date: November 2012
• Source: Sydney Centre for Reproductive Health Research
• Contact: Edith Weisberg, MB BS MM
• Phone: 61 2 8752 4342
• Email: edithw[@]fpnsw.org.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 30
• Est. completion date: August 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Women aged 18-50 years having regular menstrual cycles

• 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 for whom combined oral contraceptives are contraindicated

• 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

Related Conditions & MeSH terms

• Hemorrhage
• Menorrhagia

Intervention

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

Locations

Country	Name	City	State
Australia	SCRHR	Sydney	New South Wales

Sponsors (2)

Lead Sponsor	Collaborator
Sydney Centre for Reproductive Health Research	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Australia, 

References & Publications (1)

Fraser IS, Römer 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• The primary efficacy end-point will be the proportion of women with a reduction = 50% from baseline	A single arm open label intervention study	Baseline to outcome 12weeks
Secondary	•• A secondary efficacy endpoint will be the number and proportion of cycles with a normal blood loss = 80mls	Open label single group measuring the efficacy of a combined hormonal contraceptive to restore a normal level of MBL	•Baseline to endpoint 12 weeks