Study of a Progestin to Prevent Bleeding Associated With Initiation of Medical Menopause With GnRH Agonist
This study is currently recruiting participants.
Verified January 2013 by Kaiser Permanente
Sponsor:
Malcolm G. Munro
Information provided by (Responsible Party):
Malcolm G. Munro, Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT01776203
First received: June 14, 2011
Last updated: January 23, 2013
Last verified: January 2013
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Dysfunctional Uterine Bleeding |
Drug: Medroxyprogesterone 17-Acetate |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Initiation of Medical Menopause With Depot Leuprolide Acetate vs Depot Leuprolide Acetate Plus Medroxyprogesterone Acetate: A Pilot Randomized |
Resource links provided by NLM:
Further study details as provided by Kaiser Permanente:
Primary Outcome Measures:
- Amount of bleeding with or without use of medroxyprogesterone acetate after initiation of gonadrotropin-releasing hormone agonist therapy, [ Time Frame: 30 days ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- the number of days of bleeding, nausea, bloating, and pelvic pain [ Time Frame: 30 days ] [ Designated as safety issue: No ]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).
| Estimated Enrollment: | 40 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: medroxyprogesterone acetate |
Drug: Medroxyprogesterone 17-Acetate
MPA pills 20 mg (2 X 10 mg) twice daily for 3 weeks
Other Name: Provera
|
| No Intervention: control |
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01776203
Contacts
| Contact: Sanaz Keyhan, MD | 323-340-2561 | Sanaz.X.Keyhan@kp.org |
| Contact: Malcolm Munro, MD | 323-783-4211 | M.G.Munro@kp.org |
Locations
| United States, California | |
| Kaiser Permanente | Recruiting |
| Los Angeles, California, United States, 90027 | |
| Contact: Sanaz Keyhan, MD | |
| Sub-Investigator: Sanaz Keyhan, MD | |
Sponsors and Collaborators
Malcolm G. Munro
Investigators
| Principal Investigator: | Malcolm Munro, MD | Kaiser Permanente |
More Information
No publications provided
| Responsible Party: | Malcolm G. Munro, Principal Investigator, Kaiser Permanente |
| ClinicalTrials.gov Identifier: | NCT01776203 History of Changes |
| Other Study ID Numbers: | 20110523 |
| Study First Received: | June 14, 2011 |
| Last Updated: | January 23, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Hemorrhage Metrorrhagia Uterine Hemorrhage Pathologic Processes Uterine Diseases Genital Diseases, Female Medroxyprogesterone Medroxyprogesterone Acetate Leuprolide Contraceptives, Oral, Synthetic Contraceptives, Oral |
Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Contraceptive Agents, Male Antineoplastic Agents, Hormonal Antineoplastic Agents Fertility Agents, Female Fertility Agents |
ClinicalTrials.gov processed this record on May 21, 2013