drugset / Trial / NCT05751252

Sub-therapeutic GnRH- Antagonist Treatment to Rectify LH Pulsatility in Lean Women With PCOS.

NCT05751252

Phase 0 Completed 20 enrolled University Hospital, Lille
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The clinical study using a sub-therapeutic dose of a GnRH antagonist to reduce overactive LH pulsatility in women with PCOS. With the intervention and lowered LH action we anticipate to decrease androgen levels in women with PCOS. The aim to show for the first time that low-dose GnRH-antagonists can lower LH pulsatility by 20-30% and decrease androgen levels without blunting the hypothalamic-pituitary-gonadal axis and thereby the reproductive functions.

Timeline

Start
2024-04-17
Primary completion
2025-02-09
Completion
2025-02-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Ganirelix Protein / enzyme biologic 0.025 mg Subcutaneous
Subject Ganirelix Protein / enzyme biologic 0.0625 mg Subcutaneous