Study to Evaluate the Pharmacodynamics and Efficacy of Leuprolide Tablets (Ovarest®) in Women With Endometriosis

What Was Tested

The trial (phase 2) is built around Leuprolide for endometriosis.

It had five arms (groups): one (experimental), one (experimental), one (experimental), one (experimental) and one (experimental).

The registry classes the interventions as drug.

More on the Plan

Objectives of this study: 1.

Who Took Part

16 planned participants were the target.

It was open to women only aged from 18 years up to 49 years.

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

Examples of who could join: BMI ≥18 and ≤35 kg/m2, and weight ≥110 lb. (≈50 kg). A documented estradiol level ≥ 40 pg/mL at screening or on retest. If of childbearing potential and sexually active with a risk of pregnancy, willing to use acceptable methods of contraception (Note: acceptable methods of contraception are specified in Section 8.1). Willing to refrain from the use of any hormone-containing or hormone-altering substances during the study. Willing and capable to give informed consent to participate in study.

The full record lists 10 inclusion and 39 exclusion criteria; among the exclusions: undiagnosed abnormal vaginal bleeding. note: this is a contraindication from the lupron depot label; breastfeeding or within 2 months after stopping breastfeeding (relative to the screening visit). note: use of lupron depot is contraindicated in women who are breastfeeding; status postpartum or postabortion within a period of 2 months prior to the screening visit.

How the Study Was Run

The set-up was non-randomized, sequential and open-label.

Everyone knew when Leuprolide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2022-03-18 with completion listed for 2022-05.

It ran at 4 sites in United States (4).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Adequacy of suppression of estradiol (E2) as assessed by the subject incidence of estradiol level below 20 pg/mL (time frame: Treatment cycle: Day 29).

It also tracked 6 secondary outcomes, for example Suppression of ovulation (as evidenced by progesterone levels <3 ng/mL), Number of vaginal (menstrual) bleeding days, Composite Pelvic Signs and Symptoms (CPSS) scores, Luteinizing hormone (LH) levels and Follicle Stimulating Hormone (FSH) levels.

What This Means in Plain Language

Put simply, this is a phase 2, non-randomized trial of Leuprolide in 16 people with endometriosis.

Its size is small, so on its own it can only give an early look.

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.