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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Kaiser Permanente
Sponsor:
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
  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:

  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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Uterine Diseases
Hemorrhage
Metrorrhagia
Uterine Hemorrhage
Pathologic Processes
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 September 14, 2014