Clinical trial NCT01715025: A New Treatment Option for Heavy Menstrual Bleeding
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Menorrhagia
Keywords: measured
heavy menstrual bleeding
combined oral contraceptive
alkaline haematin method
Lead sponsor: Sydney Centre for Reproductive Health Research
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2012-10-26
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: • The primary efficacy end-point will be the proportion of women with a reduction ≥ 50% from baseline
timeFrame: Baseline to outcome 12weeks
Secondary outcomes:
measure: •• A secondary efficacy endpoint will be the number and proportion of cycles with a normal blood loss ≤ 80mls
timeFrame: •Baseline to endpoint 12 weeks
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: SCRHR
state: New South Wales
Study officials:
affiliation: Sydney Centre for Reproductive Health Research FPNSW
name: Edith Weisberg, MB BS MM
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.