LutrePulse Hypogonadotropic Hypogonadism

What Was Tested

This registered phase 3 trial tested Gonadorelin.

To compare the ovulation rate in women with primary amenorrhea with hypogonadotropic hypogonadism following pulsatile gonadotropin-releasing hormone (GnRH) treatment using the OmniPod pump versus placebo.

It had four arms (groups): one (experimental), one (experimental), one (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 39 actual participants took part.

It was open to women only aged from 18 years up to 40 years.

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

Examples of who could join: Women 18-40 years old. Body mass index (BMI) between 18 and 38 kg/m2. Clinical history or recently diagnosed with primary amenorrhea with hypogonadotropic hypogonadism. Desire to become pregnant. Discontinued estrogen-progesterone replacement therapy at least 1 month before screening.

The full record lists 13 inclusion and 13 exclusion criteria; among the exclusions: any medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the drug; A history of adrenal or uncontrolled thyroid disorders, or hyperprolactinemia; prior treatment cycle with gonadotropins or gnrh within the last 2 months.

How the Study Was Run

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

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

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

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

Those kept unaware of assignments: participant and investigator.

It started in 2014-04-01 with completion listed for 2018-02-23.

It ran at 35 sites in United States (33) and Canada (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Ovulation Rate (time frame: From treatment Day 1 up to 4 weeks after second positive β-hCG test, approximately 9 weeks).

It also tracked 15 secondary outcomes, for example Progesterone (P4) Levels, Clinical Pregnancy Rate, Biochemical Pregnancy Rate, LH Surge Detection, Ovarian Follicular Development: Number of Follicles With a Mean Diameter Greater Than or Equal to (≥)14 mm and Ovarian Follicular Development: Number of Dominant Follicles With a Mean Diameter of ≥18 mm.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Gonadorelin in 39 people.

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 Gonadorelin compound page, all human trials.