A Study of Pharmacokinetic/Pharmacodynamic Profile of Orally Administered Leuprolide in Healthy Female Volunteers

What Was Tested

In this phase 2 trial, researchers set out to test Leuprolide for endometriosis.

Major PK (e.g., a total exposure to leuprolide) and PD parameters (e.g., rates of the estradiol suppression and cessation of the menstrual period) will also be evaluated against the Lupron Depot historical data.

It had four arms (groups): one (experimental), one (experimental), Treatment C: Leuprolide 1 month depot (active comparator) and one (experimental).

The registry classes the interventions as drug.

More on the Plan

For PD analysis, subject incidence of estradiol level below 40 pg/mL was assessed.

The ovulation rate determined by the extent of progesterone suppression is presented.

No attempt is made to impute (i.e., extrapolate or interpolate) estimates for missing data.

The Medical Dictionary for Regulatory Activities (MedDRA®) Version 20.1 is used to classify all medical history findings and incidences of treatment emergent adverse events (TEAE) reported during the study by System Organ Class (SOC) and Preferred Term (PT).

Who Took Part

35 actual participants took part.

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

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Body mass index (BMI) ≥ 18 and ≤ 32 kg/m2, and weight ≥ 110 lb (approximately 50 kg);. Intrauterine contraceptive device (IUD) without hormone release system placed at least 4 weeks prior to the first study drug administration with simultaneous use of condom for the male partner;. Simultaneous use of diaphragm with intravaginally applied spermicide and condom for the male partner starting at least 14 days prior to drug administration;. 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 was 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® was contraindicated in women who were breastfeeding;; status postpartum or post-abortion within a period of 2 months prior to the screening visit;.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Leuprolide and who got the comparison, which limits bias.

The Leuprolide group and the comparison group ran side by side rather than switching.

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 2017-08-23 with completion listed for 2018-06-27.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Number of Participants With Adequacy of Suppression of Estradiol (E2) as Assessed by Estradiol Level Below 40 pg/mL. Ovulation Rate - Measured by Number of Subjects With Progesterone Levels Not Less Than 3000 pg/mL. Number of Subjects Who Experienced Treatment Emergent Adverse Events (TEAE) Excluding Menstrual Disorders.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Leuprolide in 35 people with endometriosis.

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

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Leuprolide compound page, Endometriosis research.