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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| • 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 |
| Measure | Description | Time Frame |
|---|---|---|
| •• 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Edith Weisberg, MB BS MM | Sydney Centre for Reproductive Health Research FPNSW | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SCRHR | Recruiting | Sydney | New South Wales | 2131 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21784734 | Background | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 15, 2016 | |
| Reset | Jul 29, 2016 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 15, 2016 | Jul 29, 2016 |
| ID | Term |
|---|---|
| D008595 | Menorrhagia |
| ID | Term |
|---|---|
| D014592 | Uterine Hemorrhage |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008599 | Menstruation Disturbances |