Dysfunctional Uterine BleedingPhase 4NCT01148420
DMPA & High Dose Oral Progestin (MPA) Tablets in Outpatient Treatment of Acute Excessive Vaginal Bleeding
A Phase 4 study testing Medroxyprogesterone 17-Acetate and medroxyprogesterone acetate in people with Dysfunctional Uterine Bleeding, run by Women's Health Care Clinic, Torrance, California at 1 site in United States.
Trial summary
The purpose of this study is to investigate the effectiveness and acceptability of high dose MPA (20mg oral 3 times a day) for 3 days combined with an injection of DMPA 150 mg intramuscularly in the treatment of acute heavy, prolonged uterine bleeding who have been identified as being eligible for outpatient management 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
- Dysfunctional Uterine Bleeding
- What is being tested?
- Medroxyprogesterone 17-Acetate and medroxyprogesterone acetate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Jul 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age 18- 50
- Non-pregnant
- Candidate for outpatient management
- Able to understand and follow instructions
- Vital signs stable
- No severe anemia
- No medical conditions requiring transfusion
Who cannot join
- Pregnancy
- Breast cancer current or in last 5 years
- Allergy to MPA or DMPA
- Previous hormonal therapies
- Unstable vital signs
- Bleeding excessive enough to require surgical therapy or hospital admission
- Desire for pregnancy in next 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Trial of Use of DMPA Injection and High Dose MPA Tablets in Outpatient
The purpose of this study is to investigate the effectiveness and acceptability of high dose MPA (20mg oral 3 times a day) for 3 days combined with an injection of DMPA 150 mg intramuscularly in the treatment of acute heavy, prolonged uterine bleeding who have been identified as being eligible for outpatient management
Read the detailed description
Excessive vaginal bleeding is a frequent problem for reproductive age women and accounts for many office and emergency room visits. This bleeding is caused by cancer, endocrinologic problems, liver failure, benign tumors of the uterus, and cervix, as well as hormone imbalances, such as anovulatory cycling.
Even though excessive vaginal bleeding is very common, there has been very little research into ways to manage it. For non-pregnant women who have stable vital signs and are not hemorrhaging or experiencing severe anemia, outpatient therapy is generally attempted. Textbooks recommend treatment with high dose oral contraceptives pills (one tablet orally 2 times a day for 5 days). Recently, Munro et al published a small study using high doses of oral progestin (MPA 20mg 3 times daily for 7 days then one daily for 21 days). The median time to bleeding cessation was 3 days. Munro reported having difficulty enrolling adequate numbers of patients to achieve the statistical significance.
The investigators propose a pilot project to study clinical responses to a new hormonal therapy the blends the high dose oral therapy with the longer acting injectable progestin. The pilot clinical trial is designed to study 50 women who are bleeding and whose treatment is amenable to outpatient therapy. Routine care will be provided to each of the women before she is approached for study enrollment.
This study, therefore, is designed to provide short term proven therapy of 20 mg MPA tablets 3 times a day for 3 days combined with the injectable progestin (DMPA) that lasts for 3 months.
Patients will be called within 24 hours and 48 hours following their first study visit to ascertain their bleeding status and their use of medication, as well as any significant side effects they may be experiencing. Patients will be asked to return to the clinic on day 3 for a repeat hemoglobin and interval history. Those women who are still having any bleeding on day 3 will be contacted on day 5.
The primary outcome measures of the part of the study will be the time elapsed to slowing acute bleeding as well as compliance with study medications. The patient's time to complete cessation of bleeding and percent of women having complete bleeding cessation will also be calculated. Results of the biopsies done before randomization will also be evaluated to see if they had any influence on study outcomes. From the degree of responses seen in this pilot study, a larger clinical trial may be designed.
- Conditions
- Dysfunctional Uterine Bleeding
- Being tested
- Medroxyprogesterone 17-Acetate, medroxyprogesterone acetate
- Medical subject headings
- Metrorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medroxyprogesterone 17-AcetateDrug
Also called Provera, Cycrin
Medroxyprogesterone 20mg orally 3 times a day for 3 days
medroxyprogesterone acetateDrug
Also called Depo Provera Injection
Depo Provera 150mg Intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| DMPA & MPA | Experimental | 150 mg intramuscularly received DMPA and two 10 mg tablets of MPA every 8 hours for 3 days Receives: Drug: Medroxyprogesterone 17-Acetate; Drug: medroxyprogesterone acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cessation of Bleeding Within 5 Days
Patients were called within 24 hours and 48 hours following their first study visit to ascertain their bleeding status and their use of medication, as well as any significant side effects they msy have been experiencing. Patients were asked to return to the clinic on day 3 for a repeat hemoglobin and interval history. Those women who were still having any bleeding on day 3 were contacted on day 5
Measured: 3-5 days
Secondary outcomes (2)
Patient Perception of the Acceptability of the Treatment
Results from a survey question that assessed the subjects' satisfaction with the therapy on a scale of 1-3. 1 = poor; 2 = good; 3 = excellent.
Measured: End of the trial; up to day 5
Satisfaction and Willingness to Recommend Treatment
Participants were asked whether they would recommend this treatment to a friend
Measured: End of the trial; up to day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startJan 2009
- Primary completionOct 2010
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Dysfunctional Uterine BleedingStudies 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Women's Health Care Clinic, Torrance, California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anita Nelson, Women's Health Care Clinic, Torrance, California
- Investigators
- Anita L. Nelson, M.D., Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01148420
- Sponsor's protocol ID
- 13530-01
- Status last verified
- Feb 2014
- First submitted
- 21 Jun 2010
- Last updated
- 13 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Speroff L, Fritz MA. Clinical Gynecologic Endocrinology and Infertility, 7th ed. Philadelphia: Lippincott Williams & Wilkins, 2005
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 17012455Munro MG, New Concepts in nongestational acute uterine bleeding.Contemporary Ob-GYN;53(1):52-57
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial of Use of DMPA Injection and High Dose MPA Tablets in Outpatient
- ClinicalTrials.gov ID
- NCT01148420
- Acronym / sponsor ID
- 13530-01
- Conditions
- Dysfunctional Uterine Bleeding
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Women's Health Care Clinic, Torrance, CaliforniaUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 22 Jun 2010 (estimated)
- Results
- Posted 11 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the effectiveness and acceptability of high dose MPA (20mg oral 3 times a day) for 3 days combined with an injection of DMPA 150 mg intramuscularly in the treatment of acute heavy, prolonged uterine bleeding who have been identified as being eligible for outpatient management
Detailed description
Excessive vaginal bleeding is a frequent problem for reproductive age women and accounts for many office and emergency room visits. This bleeding is caused by cancer, endocrinologic problems, liver failure, benign tumors of the uterus, and cervix, as well as hormone imbalances, such as anovulatory cycling.
Even though excessive vaginal bleeding is very common, there has been very little research into ways to manage it. For non-pregnant women who have stable vital signs and are not hemorrhaging or experiencing severe anemia, outpatient therapy is generally attempted. Textbooks recommend treatment with high dose oral contraceptives pills (one tablet orally 2 times a day for 5 days). Recently, Munro et al published a small study using high doses of oral progestin (MPA 20mg 3 times daily for 7 days then one daily for 21 days). The median time to bleeding cessation was 3 days. Munro reported having difficulty enrolling adequate numbers of patients to achieve the statistical significance.
The investigators propose a pilot project to study clinical responses to a new hormonal therapy the blends the high dose oral therapy with the longer acting injectable progestin. The pilot clinical trial is designed to study 50 women who are bleeding and whose treatment is amenable to outpatient therapy. Routine care will be provided to each of the women before she is approached for study enrollment.
This study, therefore, is designed to provide short term proven therapy of 20 mg MPA tablets 3 times a day for 3 days combined with the injectable progestin (DMPA) that lasts for 3 months.
Patients will be called within 24 hours and 48 hours following their first study visit to ascertain their bleeding status and their use of medication, as well as any significant side effects they may be experiencing. Patients will be asked to return to the clinic on day 3 for a repeat hemoglobin and interval history. Those women who are still having any bleeding on day 3 will be contacted on day 5.
The primary outcome measures of the part of the study will be the time elapsed to slowing acute bleeding as well as compliance with study medications. The patient's time to complete cessation of bleeding and percent of women having complete bleeding cessation will also be calculated. Results of the biopsies done before randomization will also be evaluated to see if they had any influence on study outcomes. From the degree of responses seen in this pilot study, a larger clinical trial may be designed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DMPA & MPA | Experimental | Drug: Medroxyprogesterone 17-Acetate, Drug: medroxyprogesterone acetate150 mg intramuscularly received DMPA and two 10 mg tablets of MPA every 8 hours for 3 days |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age 18- 50
- Non-pregnant
- Candidate for outpatient management
- Able to understand and follow instructions
- Vital signs stable
Key exclusion criteria (7 listed)
- Pregnancy
- Breast cancer current or in last 5 years
- Allergy to MPA or DMPA
- Previous hormonal therapies
- Unstable vital signs
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 |
|---|---|---|
| Medroxyprogesterone 17-AcetateAlso: Provera, CycrinMedroxyprogesterone 20mg orally 3 times a day for 3 days | Drug | DMPA & MPA |
| medroxyprogesterone acetateAlso: Depo Provera InjectionDepo Provera 150mg Intramuscular injection | Drug | DMPA & MPA |
Primary outcome
Cessation of Bleeding Within 5 Days
Time frame: 3-5 days
Patients were called within 24 hours and 48 hours following their first study visit to ascertain their bleeding status and their use of medication, as well as any significant side effects they msy have been experiencing. Patients were asked to return to the clinic on day 3 for a repeat hemoglobin and interval history. Those women who were still having any bleeding on day 3 were contacted on day 5
2 secondary outcomes
Patient Perception of the Acceptability of the Treatment
Time frame: End of the trial; up to day 5
Satisfaction and Willingness to Recommend Treatment
Time frame: End of the trial; up to day 5
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundSperoff L, Fritz MA. Clinical Gynecologic Endocrinology and Infertility, 7th ed. Philadelphia: Lippincott Williams & Wilkins, 2005
- Background: 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.
- BackgroundMunro MG, New Concepts in nongestational acute uterine bleeding.Contemporary Ob-GYN;53(1):52-57
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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.
Anita L. Nelson, M.D. principal investigator
University of California, Los Angeles
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 Medroxyprogesterone 17-Acetate and medroxyprogesterone acetate in people with Dysfunctional Uterine Bleeding, run by Women's Health Care Clinic, Torrance, California 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 7 inclusion and 7 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 13 Mar 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 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.
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?
Yes. Results are posted in the registry (first posted 11 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cessation of Bleeding Within 5 Days (time frame: 3-5 days). 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 NCT01148420, which also lists 3 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 13 Mar 2014.