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

NCT ID: NCT05751252

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-17
• Study Completion Date: 2025-02-09

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.

Conditions

Polycystic Ovary Syndrome

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

0.0625 mg

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

Group Type: EXPERIMENTAL

Ganirelix

Intervention Type: DRUG

An intra-venous cannula will be inserted and blood will be sampled at 10-min intervals for a 4-h baseline period commencing at 0800 h. Ganirelix will be then administered subcutaneously at single-dose regimen at 0.025 mg (n = 10 women with PCOS). After Ganirelix administration sampling will continue at 10-min intervals for 4 h.

0.025 mg

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.

Group Type: EXPERIMENTAL

Ganirelix

Intervention Type: DRUG

An intra-venous cannula will be inserted and blood will be sampled at 10-min intervals for a 4-h baseline period commencing at 0800 h. Ganirelix will be then administered subcutaneously at single-dose regimen at 0.0625 mg (n = 10 women with PCOS). After Ganirelix administration sampling will continue at 10-min intervals for 4 h.

Interventions

Ganirelix

An intra-venous cannula will be inserted and blood will be sampled at 10-min intervals for a 4-h baseline period commencing at 0800 h. Ganirelix will be then administered subcutaneously at single-dose regimen at 0.0625 mg (n = 10 women with PCOS). After Ganirelix administration sampling will continue at 10-min intervals for 4 h.

Intervention Type: DRUG

Ganirelix

An intra-venous cannula will be inserted and blood will be sampled at 10-min intervals for a 4-h baseline period commencing at 0800 h. Ganirelix will be then administered subcutaneously at single-dose regimen at 0.025 mg (n = 10 women with PCOS). After Ganirelix administration sampling will continue at 10-min intervals for 4 h.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sophie Catteau-Jonard, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

Hôpital Jeanne de Flandre

Lille, , France

Countries

France

Other Identifiers

2023-000176-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2022_0016

Identifier Type: -

Identifier Source: org_study_id