NCT05751252

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Apr 2024

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 2, 2023

Completed
1.1 years until next milestone

Study Start

First participant enrolled

April 17, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 9, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 9, 2025

Completed
Last Updated

April 27, 2025

Status Verified

April 1, 2025

Enrollment Period

10 months

First QC Date

February 20, 2023

Last Update Submit

April 23, 2025

Conditions

Polycystic Ovary Syndrome

Keywords

PCOSGnRH antagonistLHandrogentestosterone

Outcome Measures

Primary Outcomes (1)

  • Serum LH level

    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.

    every 10 minutes for 8 hours

Secondary Outcomes (5)

  • 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

  • Variation in androgen production

    at 4 hours after injection

  • change in FSH levels

    at 4 hours post-injection

  • change in estradiol levels

    at 4 hours post-injection

  • change in AMH levels

    at 4 hours post-injection

Study Arms (2)

0.0625 mg

EXPERIMENTAL

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

Drug: Ganirelix

0.025 mg

EXPERIMENTAL

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.

Drug: Ganirelix

Interventions

GanirelixDRUG

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.

0.025 mg

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPatients followed in endocrine gynecology consultation in the Jeanne de Flandre department
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Jeanne de Flandre

Lille, 59037, France

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

ganirelix

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • Sophie Catteau-Jonard, MD,PhD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2023

First Posted

March 2, 2023

Study Start

April 17, 2024

Primary Completion

February 9, 2025

Study Completion

February 9, 2025

Last Updated

April 27, 2025

Record last verified: 2025-04

Locations

FR(1)