Clinical Trial: Treatment of Endometriosis With Norethindrone Acetate ( NA) VS. Gonadotropin- Releasing Hormone (GnRH) Agonist (Lupron Depot 11.25 mg)

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Treatment of Endometriosis With Norethindrone Acetate ( NA) VS. Gonadotropin- Releasing Hormone (GnRH) Agonist (Lupron Depot 11.25 mg)

Brief Summary: (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.

Detailed Summary:

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 f
Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Current Primary Outcome:

  • 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.


Original Primary Outcome:

  • To compare the effectiveness of norethindrone acetate (NA) with GnRH agonist (Lupron-Depot-3) in relieving symptoms of endometriosis
  • to compare bone density in the two treated groups in order to demonstrate that NA does not affect bone density


Current Secondary Outcome:

  • 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


Original Secondary Outcome:

  • 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
  • To determine whether quality of life, assessed by questionnaire, is better in patients assigned to NA than in patients assigned to GnRH


Information By: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Dates:
Date Received: April 9, 2007
Date Started: August 2004
Date Completion:
Last Updated: October 24, 2012
Last Verified: October 2012