Study of a Progestin to Prevent Bleeding Associated With Initiation of Medical Menopause With GnRH Agonist
Stopped early · Phase 4
Conditions studied: Dysfunctional Uterine Bleeding
In brief
In this study, the investigators would like to see if giving medroxyprogesterone acetate for 3 weeks after Leuprolide acetate injection will help to decrease this amount of bleeding, decrease the amount of nausea, bloating and cramping and increase patient satisfaction
Key facts
- Study ID
- NCT01776203
- Run by
- Kaiser Permanente
- People needed
- 8
- Starts
- 2012-01-01
- Expected to finish
- 2014-04-01
- Last updated by the study team
- 2015-03-17
Who can join
Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Premenopausal women 18-50 years of age
- Requiring gonadrotropin-releasing hormone agonist for any indication except ovulation induction
- If there is abnormal uterine bleeding, such bleeding is not obviously related to structural defects such as polyps or submucous leiomyomas; subserosal and intramural myomas (International Federation of Gynecology and Obstetrics Classification 3-8 inclusive) are acceptable
You may not qualify if…
- Currently pregnant
- Recent used of gonadrotropin-releasing hormone agonist
- 1 month depot formulation eg leuprolide acetate 3.75, within 90 days
- 3 month depot formulation eg leuprolide acetate 11.25 within 180 days
- Currently has an intrauterine contraceptive device
- Currently on gonadal steroids (including birth control pills, rings, or implantable or injectable agents)
- History of breast cancer
- Currently undergoing ovulation induction
- History of adverse reactions to gonadal steroids
- Hemoglobin <8 mg/dl as measured within 30 days of enrollment (Baseline hemoglobin is standard of care for patients initiating gonadrotropin-releasing hormone agonist therapy)
- Weight above >250 lbs
- Has a known submucous leiomyoma ( International Federation of Gynecology and Obstetrics Class type 0, 1, 2)
Where it is running
- Kaiser Permanente — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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