A New Treatment Option for Heavy Menstrual Bleeding

NCT01715025 | Unknown Phase 4

• 1 other identifier: R2012-7
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

measured; heavy menstrual bleeding; combined oral contraceptive; alkaline haematin method

Outcome Measures

Primary Outcomes (1)

• • 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 Outcomes (1)

• •• A secondary efficacy endpoint will be the number and proportion of cycles with a normal blood loss ≤ 80mls

  •Baseline to endpoint 12 weeks

Study Arms (1)

E2/Nomac

EXPERIMENTAL

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.

Drug: E2Nomac

Interventions

E2Nomac DRUG

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

Also known as: Zoely

E2/Nomac

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sydney Centre for Reproductive Health Research: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

SCRHR

Sydney, New South Wales, 2131, Australia

RECRUITING

Related Publications (1)

• Fraser IS, Romer 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.

  PMID: 21784734 BACKGROUND

MeSH Terms

Conditions

Menorrhagia

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances

Study Officials

• Edith Weisberg, MB BS MM

  Sydney Centre for Reproductive Health Research FPNSW

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Edith Weisberg, MB BS MM

CONTACT

61 2 8752 4342; edithw@fpnsw.org.au

Jane Hangan, RN

CONTACT

61 409 091 511; janeh@fpnsw.org.au

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2012
• First Posted: October 26, 2012
• Study Start: April 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: August 1, 2015
• Last Updated: November 19, 2014

Record last verified: 2012-11

Locations

AU (1)