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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01776203
Recruitment Status : Terminated (Inadequate enrollment)
First Posted : January 28, 2013
Last Update Posted : March 17, 2015
Information provided by (Responsible Party):
Kaiser Permanente

Brief 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

Condition or disease Intervention/treatment Phase
Dysfunctional Uterine Bleeding Drug: Medroxyprogesterone 17-Acetate Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
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
Study Start Date : January 2012
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding Menopause

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. 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).

Information from the National Library of Medicine

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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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01776203

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

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Responsible Party: Kaiser Permanente Identifier: NCT01776203     History of Changes
Other Study ID Numbers: 20110523
First Posted: January 28, 2013    Key Record Dates
Last Update Posted: March 17, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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Uterine Hemorrhage
Pathologic Processes
Uterine Diseases
Genital Diseases, Female
Medroxyprogesterone Acetate
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