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

This study has been terminated.
(Inadequate enrollment)
Information provided by (Responsible Party):
Kaiser Permanente Identifier:
First received: June 14, 2011
Last updated: March 10, 2015
Last verified: March 2015
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
Intervention Model: Single Group Assignment
Masking: None (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 ]
    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 ]
    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).

Enrollment: 8
Study Start Date: January 2012
Study Completion Date: April 2014
Primary Completion Date: April 2014 (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


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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 identifier: NCT01776203

United States, California
Kaiser Permanente
Los Angeles, California, United States, 90027
Sponsors and Collaborators
Kaiser Permanente
Principal Investigator: Malcolm Munro, MD Kaiser Permanente
  More Information

Responsible Party: Kaiser Permanente Identifier: NCT01776203     History of Changes
Other Study ID Numbers: 20110523
Study First Received: June 14, 2011
Last Updated: March 10, 2015

Additional relevant MeSH terms:
Uterine Hemorrhage
Pathologic Processes
Uterine Diseases
Genital Diseases, Female
Medroxyprogesterone Acetate
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Contraceptive Agents, Male processed this record on September 21, 2017