Treatment of Endometriosis With Norethindrone Acetate ( NA) VS. Gonadotropin- Releasing Hormone (GnRH) Agonist (Lupron Depot [amount hidden])

What Was Tested

In this phase 3 trial, researchers set out to test Leuprolide for endometriosis.

It had two arms (groups): NA alone (active comparator) and LD then NA (active comparator).

The registry classes the interventions as drug.

More on the Plan

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.

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.

Who Took Part

The registry lists 112 planned participants were the target.

It was open to women only aged from 18 years up to 55 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: The subject has voluntarily signed the Informed Consent form after having the contents fully explained, after all questions are answered and prior to undergoing any study-related procedures. The subject is a pre-menopausal female at least 18 years of age at the time of screening having regular periods (21-42 days intervals) with no menopausal symptoms. Serum pregnancy and urine qualitative pregnancy tests performed at screening and on baseline must be negative. Less than grade III overweight or BMI \<40 kg/M2.

The full record lists 8 inclusion and 5 exclusion criteria.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

The endometriosis participants were allocated by chance, so the Leuprolide group and the comparison group should start out alike.

Groups ran in parallel: each of the endometriosis participants stayed in one arm throughout.

Neither the endometriosis participants nor the staff measuring them knew who was on Leuprolide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2004-08 with completion listed for 2012-12.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: To compare effect of norethindrone acetate (NA) with GnRH agonist (Lupron-Depot-3)on bone density (time frame: 52 weeks of treatment).

It also tracked 2 secondary outcomes, for example To compare the effect of norethindrone acetate (NA) with GnRH agonist (Lupron-Depot-3)on lipid profiles and To determine the effect treatment has on quality of life.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Leuprolide in 112 people with endometriosis.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Leuprolide compound page, Endometriosis research.