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

University Hospital, Lille

Status and phase: Completed; Early Phase 1

Conditions: Polycystic Ovary Syndrome

Treatments: Drug: Ganirelix

Study type: Interventional

Funder types: Other

Identifiers

NCT05751252

2022_0016

2023-000176-35 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

0.0625 mg

Experimental group

Description:

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

Treatment:

Drug: Ganirelix

Drug: Ganirelix

0.025 mg

Experimental group

Description:

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.

Treatment:

Drug: Ganirelix

Drug: Ganirelix