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

NCT01776203 | Terminated Phase 4

• 1 other identifier: 20110523
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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

Conditions

Dysfunctional Uterine Bleeding

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• the number of days of bleeding, nausea, bloating, and pelvic pain

  30 days

Study Arms (2)

medroxyprogesterone acetate

ACTIVE COMPARATOR

Drug: Medroxyprogesterone 17-Acetate

control

NO INTERVENTION

Interventions

Medroxyprogesterone 17-Acetate DRUG

MPA pills 20 mg (2 X 10 mg) twice daily for 3 weeks

Also known as: Provera

medroxyprogesterone acetate

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Currently pregnant
• Recent used of gonadrotropin-releasing hormone agonist
• month depot formulation eg leuprolide acetate 3.75, within 90 days
• 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)

Sponsors & Collaborators

• Kaiser Permanente: lead

Study Sites (1)

Kaiser Permanente

Los Angeles, California, 90027, United States

Location

MeSH Terms

Conditions

Metrorrhagia

Interventions

Medroxyprogesterone Acetate

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Medroxyprogesterone; Hydroxyprogesterones; Progesterone; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Malcolm Munro, MD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2011
• First Posted: January 28, 2013
• Study Start: January 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: March 17, 2015

Record last verified: 2015-03

Locations

US (1)