To Compare the Safety and Pharmacokinetics of PT105 With PT105R in Healthy Postmenopausal Female Volunteers

What Was Tested

In this phase 1 trial, researchers set out to test Leuprolide.

It had two arms (groups): A (other) and B (other).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 40 planned participants were the target.

It was open to women only aged from 19 years with no upper age limit.

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

Examples of who could join: A healthy woman who is over 19 years of age and has been certified obstetrically with menopause, at the time of screening. Subjects weighing over 50 kg with BMI between 18 and 30 kg/m2 (inclusive) at screening visit.

The full record lists 2 inclusion and 4 exclusion criteria; among the exclusions: those whose plasma ast and alt exceed 2 times to the upper limit of the normal range in screening including additional examinations prior to randomization; subjects who have participated and taken investigational drug in any other clinical trial (including bioequivalence study) within six months prior to study drug administration; subjects who have donated a unit of whole blood within two months or blood components within one month prior to study drug administration.

How the Study Was Run

It was run as a randomized, crossover and double-blind study.

Because people in this Leuprolide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

In the crossover set-up each of the participants took both Leuprolide and the comparison in turn, acting as their own control.

As a double-blind Leuprolide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2021-03-11 with completion listed for 2021-07-20.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): AUC7-t of Leuprolide (time frame: 0h, 0.5, 1, 2, 4, 8, 12, 24, 72, 168, 240, 336, 504, 672, 840, 1008 hr). AUCt of Leuprolide (time frame: 0h, 0.5, 1, 2, 4, 8, 12, 24, 72, 168, 240, 336, 504, 672, 840, 1008 hr). AUCinf of Leuprolide (time frame: 0h, 0.5, 1, 2, 4, 8, 12, 24, 72, 168, 240, 336, 504, 672, 840, 1008 hr).

It also tracked 2 secondary outcomes, for example Tmax of Leuprolide and t1/2 of Leuprolide.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Leuprolide in 40 people.

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

More context: the Leuprolide compound page, all human trials.