Uterine HemorrhageNCT00350480
Treatment of Non-Gestational Acute Uterine Bleeding: A Randomized Trial
A study testing Provera in people with Uterine Hemorrhage and Menorrhagia, run by Kaiser Permanente at 1 site in United States.
Trial summary
To determine the relative efficacy of multidose medroxyprogesterone acetate (MPA, Provera) and a multidose, monophasic combination oral contraceptive in the treatment of hemodynamically stable women with non-gestational, acute uterine bleeding. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Uterine Hemorrhage, Menorrhagia
- What is being tested?
- Provera
- Type of treatment
- Pill or oral medicine
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2003to Jun 2005
- 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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-pregnant Hemodynamically stable Reproductive-aged women >18 years Present with acute uterine bleeding
Who cannot join
- Pregnant Non-hemodynamically stable <18 years
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Sunset
Los Angeles, California, 90027
About this study
Official title: Treatment of Non-Gestational Acute Uterine BleedingComparing Oral Medroxyprogesterone Acetate and Monophasic Oral Contraceptives Containing Norethindrone and Ethinyl Estradiol
To determine the relative efficacy of multidose medroxyprogesterone acetate (MPA, Provera) and a multidose, monophasic combination oral contraceptive in the treatment of hemodynamically stable women with non-gestational, acute uterine bleeding.
Read the detailed description
Acute uterine bleeding, unrelated to pregnancy, is a relatively common problem that causes many reproductive-aged women to requite emergent medical and/or surgical intervention. Although the traditional approaches have generally been surgical in nature, many practitioners utilize medical methods to arrest the bleeding. However, despite widespread use, there exists a paucity of information regarding the effectiveness, side-effects, and patient satisfaction associated with the commonly-used medical regimens. (b) The purpose of the study is to compare the efficacy of multidose medroxyprogesterone acetate and a multidose, monophasic combined oral contraceptive in the treatment of hemodvnamically-stable women with non-gestational, acute uterine bleeding.
(c) Non-pregnant, hemodynamically-stable, reproductive-aged, women, over the age of IS, who present either to the emergency area or to KP practitioner's offices with acute uterine bleeding, will be considered for eligibility. If, following a full exam and medically appropriate investigations medical management is deemed appropriate, they will be approached by a member of the investigating team for possible inclusion into the study. Following informed consent, patients will be randomized to receive either medroxyprogesterone acetate (20 mg three times daily for 7 days) or monophasic oral contraceptive containing I mg of norethindrone and 35 ug of ethinyl estradiol (three dines daily for seven days). Following the seven days of therapy, those randomized to MPA will continue with 20 mg per day for three weeks while those randomized to oral contraceptives will take one pill per day for three weeks, each completing a total of four weeks of therapy. The primary outcome will be the number of days until cessation of bleeding. Other outcomes measured will include pad and tampon counts, and hemoglobin levels. Chi square tests and student t will be used to evaluate differences between the two treatment groups. The hope is that this study will elucidate on the efficacy of the two regimens.
- Conditions
- Uterine Hemorrhage, Menorrhagia
- Being tested
- Provera, Combination Birth Control pills
- Keywords
- acute uterine bleeding
- Medical subject headings
- Uterine Hemorrhage, Menorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProveraDrug
Combination Birth Control pillsDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The avoidance of unscheduled surgery in the 28-day follow-up period.
To calculate the time requred from initiation of medical therapy until the cessation bleeding, comparing MPA to monophasic combination oral contraceptive pills.
Secondary outcomes (2)
The assessment of pad and tampon counts.
The assessment of hemoglobin levels, symptoms and side effects (ie: cramping, nausea and bloating) and patient satifaction with medical therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2006 (estimated)
- Study startApr 2003
- Study completionJun 2005
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 Uterine HemorrhageStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe 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
- None (open label)
- Enrolment
- 240 participants
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Malcolm G Munro, M.D., Principal investigator, Southern California Permanente Medical GroupRomie Basu, MD, Principal investigator, Southern California Permanente Medical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00350480
- Sponsor's protocol ID
- Uterine Bleeding
- Status last verified
- Mar 2015
- First submitted
- 6 Jul 2006
- Last updated
- 11 Mar 2015
- Results posted
- No
Publications
Munro MG, Mainor N, Basu R, Brisinger M, Barreda L. Oral medroxyprogesterone acetate and combination oral contraceptives for acute uterine bleeding: a randomized controlled trial. Obstet Gynecol. 2006 Oct;108(4):924-9. doi: 10.1097/01.AOG.0000238343.62063.22.
PubMed 17012455
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Non-Gestational Acute Uterine BleedingComparing Oral Medroxyprogesterone Acetate and Monophasic Oral Contraceptives Containing Norethindrone and Ethinyl Estradiol
- ClinicalTrials.gov ID
- NCT00350480
- Acronym / sponsor ID
- Uterine Bleeding
- Conditions
- Uterine Hemorrhage, Menorrhagia
- Keywords
- acute uterine bleeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- Apr 2003
- Study completion
- Jun 2005
- First posted
- 10 Jul 2006 (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 determine the relative efficacy of multidose medroxyprogesterone acetate (MPA, Provera) and a multidose, monophasic combination oral contraceptive in the treatment of hemodynamically stable women with non-gestational, acute uterine bleeding.
Detailed description
Acute uterine bleeding, unrelated to pregnancy, is a relatively common problem that causes many reproductive-aged women to requite emergent medical and/or surgical intervention. Although the traditional approaches have generally been surgical in nature, many practitioners utilize medical methods to arrest the bleeding. However, despite widespread use, there exists a paucity of information regarding the effectiveness, side-effects, and patient satisfaction associated with the commonly-used medical regimens. (b) The purpose of the study is to compare the efficacy of multidose medroxyprogesterone acetate and a multidose, monophasic combined oral contraceptive in the treatment of hemodvnamically-stable women with non-gestational, acute uterine bleeding.
(c) Non-pregnant, hemodynamically-stable, reproductive-aged, women, over the age of IS, who present either to the emergency area or to KP practitioner's offices with acute uterine bleeding, will be considered for eligibility. If, following a full exam and medically appropriate investigations medical management is deemed appropriate, they will be approached by a member of the investigating team for possible inclusion into the study. Following informed consent, patients will be randomized to receive either medroxyprogesterone acetate (20 mg three times daily for 7 days) or monophasic oral contraceptive containing I mg of norethindrone and 35 ug of ethinyl estradiol (three dines daily for seven days). Following the seven days of therapy, those randomized to MPA will continue with 20 mg per day for three weeks while those randomized to oral contraceptives will take one pill per day for three weeks, each completing a total of four weeks of therapy. The primary outcome will be the number of days until cessation of bleeding. Other outcomes measured will include pad and tampon counts, and hemoglobin levels. Chi square tests and student t will be used to evaluate differences between the two treatment groups. The hope is that this study will elucidate on the efficacy of the two regimens.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Non-pregnant Hemodynamically stable Reproductive-aged women >18 years Present with acute uterine bleeding
Key exclusion criteria (1 listed)
- Pregnant Non-hemodynamically stable <18 years
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 |
|---|---|---|
| Provera | Drug | – |
| Combination Birth Control pills | Drug | – |
Primary outcome
The avoidance of unscheduled surgery in the 28-day follow-up period.
To calculate the time requred from initiation of medical therapy until the cessation bleeding, comparing MPA to monophasic combination oral contraceptive pills.
2 secondary outcomes
The assessment of pad and tampon counts.
The assessment of hemoglobin levels, symptoms and side effects (ie: cramping, nausea and bloating) and patient satifaction with medical therapy.
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 11 Mar 2015.
- Derived from this study: PubMed 17012455Munro MG, Mainor N, Basu R, Brisinger M, Barreda L. Oral medroxyprogesterone acetate and combination oral contraceptives for acute uterine bleeding: a randomized controlled trial. Obstet Gynecol. 2006 Oct;108(4):924-9. doi: 10.1097/01.AOG.0000238343.62063.22.
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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.
Malcolm G Munro, M.D. principal investigator
Southern California Permanente Medical Group
Romie Basu, MD principal investigator
Southern California Permanente Medical Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Provera in people with Uterine Hemorrhage and Menorrhagia, run by Kaiser Permanente at 1 site in United States.
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 1 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 11 Mar 2015. 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 United States. 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?
The avoidance of unscheduled surgery in the 28-day follow-up period.. The study lists 2 primary outcomes in all. 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 NCT00350480, 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 11 Mar 2015.