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Completed

NCT Number: NCT05751252

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

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.

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Urogenital Diseases

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Hôpital Jeanne de Flandre

Lille, 59037, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ganirelix

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.

Primary outcomes

  1. Serum LH level

    Time frame: 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 outcomes

  1. Variation in LH secretion amplitude before and after Ganirelix* injection (area under the curve)

    Time frame: at the beginning and at the end of the 8 hours

  2. Variation in androgen production

    Time frame: 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.

  3. change in FSH levels

    Time frame: 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

  4. change in estradiol levels

    Time frame: 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

  5. change in AMH levels

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

Short-term GnRH- Antagonist Treatment to Lower LH Pulsatility in Women With PCOS Aiming to Improve Hormonal Functions

Acronym: SOPKGANI

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 2, 2023
Registry last updated
Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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