Dysfunctional Uterine Bleeding Clinical Trial
Official title:
Initiation of Medical Menopause With Depot Leuprolide Acetate vs Depot Leuprolide Acetate Plus Medroxyprogesterone Acetate: A Pilot Randomized
Verified date | March 2015 |
Source | Kaiser Permanente |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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
Status | Terminated |
Enrollment | 8 |
Est. completion date | April 2014 |
Est. primary completion date | April 2014 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility |
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) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Kaiser Permanente | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
Kaiser Permanente |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Amount of bleeding with or without use of medroxyprogesterone acetate after initiation of gonadrotropin-releasing hormone agonist therapy, | The primary outcome of this study will be the amount of bleeding as measured by the validated Mansfield scale experienced by patients in the 28 days following the initiation of GnRHa therapy. This scale is from 0 (no bleeding) to 6 (very heavy bleeding or gushing). The patients will fill out this diary every day for 3 weeks after receiving GnRHa therapy. | 30 days | No |
Secondary | the number of days of bleeding, nausea, bloating, and pelvic pain | 2.2 Secondary outcomes will include the number of days of bleeding, nausea, bloating, and pelvic pain. These outcomes were set to evaluate efficacy of treatment (amount of bleeding, number of days of bleeding) as well as common side effects experienced with the medications being used (nausea, bloating, pelvic pain). The pelvic pain will be meausured based on a scale from 0 (none) to 10 (worst imaginable pain). Patient's nausea, bloating and breast tenderness is based on a scale from 0 (none) to 4 (severe). | 30 days | No |
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