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

Early Phase 1

Completed

• Conditions: Polycystic Ovary Syndrome
• Interventions: Drug: Ganirelix

• Registration Number: NCT05751252
• Lead Sponsor: University Hospital, Lille

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-20
• Study First Submitted QC: 2023-02-20
• Study First Posted: 2023-03-02
• Study Start: 2024-04-17
• Primary Completion: 2025-02-09
• Study Completion: 2025-02-09
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

• Minimum weight of 51 kg
• BMI between 20 and 25
• women with PCOS with AMH> 28 pmol / L, LH> 8 IU / mL and testosteronemia > 0.39 ng/mL
• no hormonal treatment or contraception for 2 months
• women covered by the Social Security system

Exclusion Criteria

• hormonal treatment or hormonal contraception
• Metformin treatment
• pregnant woman
• inability to understand the newsletter

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.0625 mg	Ganirelix	Test the efficacy of Ganirelix administered subcutaneously at single-dose regimen of 0.0625 mg in 10 women with PCOS, in rectifying LH pulse frequency and LH amplitude
0.025 mg	Ganirelix	Test the efficacy of Ganirelix administered subcutaneously at single-dose regimen of 0.025 mg in 10 women with PCOS, in rectifying LH pulse frequency and LH amplitude.

Primary Outcome Measures

Name	Time	Method
Serum LH level	every 10 minutes for 8 hours	The degree of gonadotropin suppression will be determined by calculating the percent inhibition from the pre-antagonist period \[(mean PRE - nadir)/mean PRE\] x 100, where nadir hormone levels will be calculated using a moving average.

Secondary Outcome Measures

Name	Time	Method
change in AMH levels	at 4 hours post-injection	defined as the difference between the measurement at H8 and the measurement at H0 (4 hours prior to injection) of AMH.
Variation in androgen production	at 4 hours after injection	defined by the difference between the measurement at H8 and the measurement at H0 (4 hours before injection) of total testosterone and androstenedione.
change in FSH levels	at 4 hours post-injection	defined as the difference between the measurement at H8 and the measurement at H0 (4 hours prior to injection) of FSH
Variation in LH secretion amplitude before and after Ganirelix* injection (area under the curve)	at the beginning and at the end of the 8 hours
change in estradiol levels	at 4 hours post-injection	defined as the difference between the measurement at H8 and the measurement at H0 (4 hours prior to injection) of estradiol

Trial Locations

Locations (1)

Hôpital Jeanne de Flandre; 🇫🇷 Lille, France