Treatment of Endometriosis With Norethindrone Acetate ( NA) VS. Gonadotropin- Releasing Hormone (GnRH) Agonist (Lupron Depot 11.25 mg)
Recruitment status was: Active, not recruiting
|Endometriosis Dysmenorrhea Dyspareunia||Drug: Norethindrone Acetate (NA) Drug: GnRH Agonist (Lupron Depot)||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
|Official Title:||Treatment of Endometriosis With Norethindrone Acetate ( NA) VS. Gonadotropin- Releasing Hormone (GnRH) Agonist (Lupron Depot 11.25 mg)|
- To compare the effectiveness of norethindrone acetate (NA) with GnRH agonist (Lupron-Depot-3) in relieving symptoms of endometriosis [ Time Frame: First 24 weeks of treatment ]
- To compare effect of norethindrone acetate (NA) with GnRH agonist (Lupron-Depot-3)on bone density [ Time Frame: 52 weeks of treatment ]Bone density with be compared in the two treated groups in order to demonstrate that NA does not affect bone density.
- To compare the effect of norethindrone acetate (NA) with GnRH agonist (Lupron-Depot-3)on lipid profiles [ Time Frame: Treatment and follow-up ]Lipid profiles of patients in the two groups will be collected to confirm the hypothesis that the effects of NA and GnRH agonists on lipid profiles are similar.
- To determine the effect treatment has on quality of life [ Time Frame: Treatment and follow-up ]Quality of life will be assessed by questionnaire
|Study Start Date:||August 2004|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Active Comparator: NA alone
Norethindrone Acetate (NA) 5mg taken 1-3 tabs orally every night for duration of treatment
Drug: Norethindrone Acetate (NA)
52 weeks of treatment with Norethindrone Acetate
Active Comparator: LD then NA
Lupron Depot(LD) given intramuscularly every 12 weeks for total of 24 weeks then switched to Norethindrone Acetate (NA) taken 1-3 tablets orally every night for remainder of treatment
Drug: GnRH Agonist (Lupron Depot)
24 weeks of treatment with Lupron Depot then 28 weeks of treatment with Norethindrone Acetate
Objectives: (A) Major 1) to compare the effectiveness of norethindrone acetate (NA) with GnRH agonist (Lupron-Depot-3) in relieving symptoms of endometriosis, 2) to compare bone density in the two treated groups in order to demonstrate that NA does not affect bone density; (B) Minor: 1) To compare the lipid profiles of patients in the two groups to confirm the hypothesis that the effects of NA and GnRH agonists on lipid profiles are similar, 2) To determine whether quality of life, assessed by questionnaire, is better in patients assigned to NA than in patients assigned to GnRH, 3) To determine whether NA has fewer adverse effects than GnRH agonist.
After signing an IRB approved consent from 112 women with symptomatic endometriosis, diagnosed surgically, will be treated with NA or Lupron-Depot-3 for 24 weeks. After 24 weeks both groups will be treated only with NA until 52 weeks. After that, both groups will be followed for an additional 52 weeks to assess any return of clinical symptoms and to determine whether laboratory tests of drug related changes return to pretreatment levels.
Treatment regimens are as follows: For the first 24 weeks, women in the NA group will be treated with 5 mg NA daily and a placebo injection every 12 weeks. In case of bleeding, the NA dose will be increased (max 15 mg) until bleeding stops, and then decreased by 2.5 mg every 4 weeks to a final dose of 7.5 mg which will be maintained for the remainder of the 24 weeks. For the first 24 weeks, women in the GnRH groups will receive Lupron-Depot-3 injections every 12 weeks plus placebo pills daily - bleeding will be treated with an increase in placebo pills to simulate treatment in the NA group. After 24 weeks, all women will be on identical regimens of 5 mg NA pills daily and no injections.
On the first treatment day, subjects will have the following tests/assessments: bone density with DEXA, scoring of endometriosis symptoms, quality of life questionnaire, general physical examination, lipid profile, estradiol (E2), N-telopeptide, and pregnancy test. All tests, except bone density and lipid profile, will be repeated at 12, 24, and 52 weeks of treatment. Bone density will be performed at 24 and 52 weeks and lipid profile will be performed at 12 and 52 weeks of treatment. In the follow-up period, physical examination, quality of life questionnaires, scoring of symptoms will be done at 3, 6, 9 and 12 months. Lipid profile, N-telopeptide and E2 will be performed at 3 and 12 months and bone density at 12 month follow-up.
The objectives stated above will be compared between the two groups at 12, 24, and 52 weeks of treatment and at 6-month intervals during the follow-up period.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00458458
|United States, New York|
|SUNY Downstate Medical Center|
|Brooklyn, New York, United States, 11203|
|Principal Investigator:||Ozgul Muneyyirci-Delale, M.D.||State University of New York - Downstate Medical Center|