Study to Compare the Bioavailability, Safety and Tolerability of XM17 in Healthy, Down Regulated Young Women

What Was Tested

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

Furthermore, safety and tolerability will be assessed in human healthy female subjects.

Only female subjects will be included in the study to reach the objectives of the study.

It had three arms (groups): XM17 (experimental), Gonal-f® (experimental) and Zoladex® (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 49 actual participants took part.

It was open to women only aged from 18 years up to 39 years.

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

Examples of who could join: Having signed written informed consent. Healthy female subjects of any racial origin. 18-39 years at the time of screening. Body mass index (BMI) between 18-29 kg/m2 and a body weight of ≥ 50 kg. Use of oral contraceptives for contraceptive purposes only and not for regularization of menstrual cycle, for at least 3 months.

The full record lists 8 inclusion and 7 exclusion criteria; among the exclusions: polycystic ovary syndrome, impaired ovarian function, severe endometriosis class iii or iv, submucosal myoma uteri; history of endocrine abnormalities with treatment within the last six months; contraindications for the use of gonadotropins and goserelin.

How the Study Was Run

The set-up was randomized, crossover and open-label.

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

Each person switched between Goserelin and the comparison at some point, usually with a gap in between.

Nothing was hidden in this open-label Goserelin study: the participants and staff both knew the treatment.

It started in 2009-02 with completion listed for 2009-05.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 9 secondary outcomes, for example Percentage of participants with adverse events.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Goserelin in 49 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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