Efficiency of Gonadotropin-releasing Hormone (GnRH) Agonist in Preventing Chemotherapy Induced Ovarian Failure

What Was Tested

In this phase 2, phase 3 trial, researchers set out to test Triptorelin.

Chemotherapy drugs like alkylating agents are frequently used in various combined regimens to treat neoplastic and benign diseases.

It had two arms (groups): Arm A (GnRha arm) (experimental) and Arm B (control Arm) (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 118 actual participants took part.

It was open to women only aged from 18 years up to 45 years.

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

Examples of who could join: Women between 18 and 45 years old with lymphoma. Subject treated by chemotherapy-induced ovarian failure including alkylant agents (except less than 8 ABVD). Presence of both ovaries (ovarian biopsy or hemiovariectomy for cryopreservation before treatment is accepted). Ability to give written informed consent.

The full record lists 5 inclusion and 12 exclusion criteria; among the exclusions: hormonal-sensible malignancy; chemotherapy or radiotherapy before the inclusion in the study; pelvic irradiation including the ovaries or tbi.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

It started in 2002-07 with completion listed for 2010-06.

It ran at 15 sites in Belgium (7), France (7) and Italy (1).

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: Premature ovarian failure rate (time frame: 5 years).

It also tracked 4 secondary outcomes, for example Impact of the flare-up effect of Triptorelin, Ovarian function during the treatment, Number of Participants with Adverse Events as a Measure of Safety and Tolerability and Add back therapy effect.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Triptorelin in 118 people.

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

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