Study of a Progestin to Prevent Bleeding Associated With Initiation of Medical Menopause With GnRH Agonist

• Status: Terminated
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kaiser Permanente
• Treatments: Leuprolide; Medroxyprogesterone; Medroxyprogesterone Acetate

Criteria

Inclusion Criteria:

1. Premenopausal women 18-50 years of age

2. Requiring gonadrotropin-releasing hormone agonist for any indication except ovulation induction

3. 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

Exclusion Criteria:

1. Currently pregnant

2. Recent used of gonadrotropin-releasing hormone agonist

1. 1 month depot formulation eg leuprolide acetate 3.75, within 90 days

2. 3 month depot formulation eg leuprolide acetate 11.25 within 180 days

3. Currently has an intrauterine contraceptive device

4. Currently on gonadal steroids (including birth control pills, rings, or implantable or injectable agents)

5. History of breast cancer

6. Currently undergoing ovulation induction

7. History of adverse reactions to gonadal steroids

8. 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)

9. Weight above >250 lbs

10. Has a known submucous leiomyoma ( International Federation of Gynecology and Obstetrics Class type 0, 1, 2)