MenorrhagiaPhase 4NCT01715025
A New Treatment Option for Heavy Menstrual Bleeding
A Phase 4 study testing E2Nomac in people with Menorrhagia, run by Sydney Centre for Reproductive Health Research at 1 site in Australia.
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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menorrhagia
- What is being tested?
- E2Nomac
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteAustralia
- Study dates
- Apr 2013to Aug 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
SCRHR
Sydney, New South Wales, 2131
Edith Weisberg, MB BS MM
About this study
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)
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:
Read more
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.
Read the 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.
- Conditions
- Menorrhagia
- Being tested
- E2Nomac
- Keywords
- measured, heavy menstrual bleeding, combined oral contraceptive, alkaline haematin method
- Medical subject headings
- Menorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E2NomacDrug
Also called Zoely
Women will start the first cycle of the COC on the first day of their period in the treatment phase of the study
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: E2Nomac |
What is being measured
The primary outcome is the main question the study is designed to answer.
• The primary efficacy end-point will be the proportion of women with a reduction ≥ 50% from baseline
A single arm open label intervention study
Measured: 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
Open label single group measuring the efficacy of a combined hormonal contraceptive to restore a normal level of MBL
Measured: •Baseline to endpoint 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2012 (estimated)
- Study startApr 2013
- Primary completionApr 2015 (estimated)
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MenorrhagiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sydney Centre for Reproductive Health Research
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Edith Weisberg, MB BS MM, Principal investigator, Sydney Centre for Reproductive Health Research FPNSW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01715025
- Sponsor's protocol ID
- R2012-7
- Status last verified
- Nov 2012
- First submitted
- 23 Oct 2012
- Last updated
- 19 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21784734
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01715025
- Acronym / sponsor ID
- R2012-7
- Conditions
- Menorrhagia
- Keywords
- measured, heavy menstrual bleeding, combined oral contraceptive, alkaline haematin method
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sydney Centre for Reproductive Health ResearchUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Apr 2013
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 26 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| E2/Nomac | Experimental | Drug: E2NomacWomen 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E2NomacAlso: ZoelyWomen will start the first cycle of the COC on the first day of their period in the treatment phase of the study | Drug | E2/Nomac |
Primary outcome
• The primary efficacy end-point will be the proportion of women with a reduction ≥ 50% from baseline
Time frame: Baseline to outcome 12weeks
A single arm open label intervention study
1 secondary outcome
•• A secondary efficacy endpoint will be the number and proportion of cycles with a normal blood loss ≤ 80mls
Time frame: •Baseline to endpoint 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2014.
- Background: PubMed 21784734Fraser 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edith Weisberg, MB BS MM principal investigator
Sydney Centre for Reproductive Health Research FPNSW
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing E2Nomac in people with Menorrhagia, run by Sydney Centre for Reproductive Health Research at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Edith Weisberg, MB BS MM (61 2 8752 4342, edithw@fpnsw.org.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• The primary efficacy end-point will be the proportion of women with a reduction ≥ 50% from baseline (time frame: Baseline to outcome 12weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01715025, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2014.