MenorrhagiaNCT01266759
Efficacy of Combined Contraceptive Vaginal Ring(NuvaRing)in Women With Idiopathic Menorrhagia
A study testing NuvaRing and Norethisterone Acetate tablets - 5mg in people with Menorrhagia, run by Mansoura University at 1 site in Egypt.
Trial summary
To compare the efficacy of a combined contraceptive vaginal ring (NuvaRing) and oral Norethisterone Acetate in treatment of Idiopathic heavy menstrual bleeding during fertile age Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Menorrhagia
- What is being tested?
- NuvaRing and Norethisterone Acetate tablets - 5mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteEgypt
- Study dates
- Jul 2008to Sep 2010
- Phase
- Interventional
- 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 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women with heavy menstrual bleeding based on PBAC score over 185 (mean of two control cycles)and desire contraception
Who cannot join
- Menorrhagia of endocrine or systemic origin
- other pathology e.g. patients with fibroids of any size, adenomyosis, endometriosis, pelvic inflammatory disease.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura University Hospitals,OB/GYN department
Al Mansurah, Dakahlia Governorate
About this study
Official title: Combined Contraceptive Vaginal Ring or Norethisterone for Treatment of Idiopathic Menorrhagia
To compare the efficacy of a combined contraceptive vaginal ring (NuvaRing) and oral Norethisterone Acetate in treatment of Idiopathic heavy menstrual bleeding during fertile age
- Conditions
- Menorrhagia
- Being tested
- NuvaRing, Norethisterone Acetate tablets - 5mg
- Keywords
- Menorrhagia, Vaginal ring, Norethisterone Acetate
- Medical subject headings
- Menorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NuvaRingDrug
For the first cycle, women inserted the ring between days 1 and 5 of the menstrual cycle. Treatment continued for three cycles. Each cycle consisted of 3 weeks of ring use followed by a 1 week ring-free period.
Norethisterone Acetate tablets - 5mgDrug
Norethisterone Acetate tablets 5 mg three times daily from day 5 to 26 of the cycle over three cycles. Male condom used for contraception during treatment
| Study group | Role | What they receive |
|---|---|---|
| NuvaRing | Experimental | For the first cycle, women inserted the ring between days 1 and 5 of the menstrual cycle. Treatment continued for three cycles. Each cycle consisted of 3 weeks of ring use followed by a 1 week ring-free period. Receives: Drug: NuvaRing |
| Norethisterone Acetate | Active comparator | Norethisterone Acetate tablets at a dose of 5 mg three times daily from day 5 to 26 of the cycle over three cycles. Male condom used for contraception during treatment Receives: Drug: Norethisterone Acetate tablets - 5mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in menstrual blood loss at the end of study (cycle 3) measured by pictorial blood loss assessment chart.
Secondary outcomes (1)
Haemoglobin and serum ferritin at the end of study (cycle 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2010 (estimated)
- Study startJul 2008
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MenorrhagiaStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Investigators
- Hatem Abu Hashim, MD MRCOG, Principal investigator, Mansoura University HospitalWaleed El-Sherbini, MD, Study director, Mansoura University HospitalMohamed Bazeed, MD, Study chair, Mansoura University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01266759
- Sponsor's protocol ID
- MU-261z
- Other IDs
- FMH-245-C
- Status last verified
- Dec 2010
- First submitted
- 22 Dec 2010
- Last updated
- 24 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Matteson KA, Boardman LA, Munro MG, Clark MA. Abnormal uterine bleeding: a review of patient-based outcome measures. Fertil Steril. 2009 Jul;92(1):205-16. doi: 10.1016/j.fertnstert.2008.04.023. Epub 2008 Jul 16.
PubMed 18635169Oddsson K, Leifels-Fischer B, Wiel-Masson D, de Melo NR, Benedetto C, Verhoeven CH, Dieben TO. Superior cycle control with a contraceptive vaginal ring compared with an oral contraceptive containing 30 microg ethinylestradiol and 150 microg levonorgestrel: a randomized trial. Hum Reprod. 2005 Feb;20(2):557-62. doi: 10.1093/humrep/deh604. Epub 2004 Nov 11.
PubMed 15539438
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Contraceptive Vaginal Ring or Norethisterone for Treatment of Idiopathic Menorrhagia
- ClinicalTrials.gov ID
- NCT01266759
- Acronym / sponsor ID
- MU-261z
- Conditions
- Menorrhagia
- Keywords
- Menorrhagia, Vaginal ring, Norethisterone Acetate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 24 Dec 2010 (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.
To compare the efficacy of a combined contraceptive vaginal ring (NuvaRing) and oral Norethisterone Acetate in treatment of Idiopathic heavy menstrual bleeding during fertile age
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NuvaRing | Experimental | Drug: NuvaRingFor the first cycle, women inserted the ring between days 1 and 5 of the menstrual cycle. Treatment continued for three cycles. Each cycle consisted of 3 weeks of ring use followed by a 1 week ring-free period. |
| Norethisterone Acetate | Active comparator | Drug: Norethisterone Acetate tablets - 5mgNorethisterone Acetate tablets at a dose of 5 mg three times daily from day 5 to 26 of the cycle over three cycles. Male condom used for contraception during treatment |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women with heavy menstrual bleeding based on PBAC score over 185 (mean of two control cycles)and desire contraception
Key exclusion criteria (2 listed)
- Menorrhagia of endocrine or systemic origin
- other pathology e.g. patients with fibroids of any size, adenomyosis, endometriosis, pelvic inflammatory disease.
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 |
|---|---|---|
| NuvaRingFor the first cycle, women inserted the ring between days 1 and 5 of the menstrual cycle. Treatment continued for three cycles. Each cycle consisted of 3 weeks of ring use followed by a 1 week ring-free period. | Drug | NuvaRing |
| Norethisterone Acetate tablets - 5mgNorethisterone Acetate tablets 5 mg three times daily from day 5 to 26 of the cycle over three cycles. Male condom used for contraception during treatment | Drug | Norethisterone Acetate |
Primary outcome
Reduction in menstrual blood loss at the end of study (cycle 3) measured by pictorial blood loss assessment chart.
1 secondary outcome
Haemoglobin and serum ferritin at the end of study (cycle 3)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2010.
- Background: PubMed 18635169Matteson KA, Boardman LA, Munro MG, Clark MA. Abnormal uterine bleeding: a review of patient-based outcome measures. Fertil Steril. 2009 Jul;92(1):205-16. doi: 10.1016/j.fertnstert.2008.04.023. Epub 2008 Jul 16.
- Background: PubMed 15539438Oddsson K, Leifels-Fischer B, Wiel-Masson D, de Melo NR, Benedetto C, Verhoeven CH, Dieben TO. Superior cycle control with a contraceptive vaginal ring compared with an oral contraceptive containing 30 microg ethinylestradiol and 150 microg levonorgestrel: a randomized trial. Hum Reprod. 2005 Feb;20(2):557-62. doi: 10.1093/humrep/deh604. Epub 2004 Nov 11.
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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.
Hatem Abu Hashim, MD MRCOG principal investigator
Mansoura University Hospital
Waleed El-Sherbini, MD study director
Mansoura University Hospital
Mohamed Bazeed, MD study chair
Mansoura University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NuvaRing and Norethisterone Acetate tablets - 5mg in people with Menorrhagia, run by Mansoura University at 1 site in Egypt.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 24 Dec 2010. 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 Egypt. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in menstrual blood loss at the end of study (cycle 3) measured by pictorial blood loss assessment chart.. 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 NCT01266759, which also lists 2 linked publications.
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 24 Dec 2010.