Phase 4
Completed N=48
DMPA & High Dose Oral Progestin (MPA) Tablets in Outpatient Treatment of Acute Excessive Vaginal Bleeding
Dysfunctional Uterine Bleeding
Source: ClinicalTrials.gov NCT01148420 ↗
Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Feb 2014
Primary outcomePrimary: Cessation of Bleeding Within 5 Days — 48 participants
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cessation of Bleeding Within 5 Days |
48 | — |
| SECONDARY Patient Perception of the Acceptability of the Treatment |
3 | — |
| SECONDARY Satisfaction and Willingness to Recommend Treatment |
48; 0 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01148420). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.