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

Early Phase 1CompletedNCT05751252

University Hospital, Lille20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Polycystic Ovary Syndrome

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.

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 0.025 mg (n = 10 women with PCOS). After Ganirelix administration sampling will continue at 10-min intervals for 4 h.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 35 Years

Medical Language ↔ Plain English

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

Locations (1)

Hôpital Jeanne de Flandre

Lille, France

Outcomes

Primary Outcomes

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.

Time frame: every 10 minutes for 8 hours

Secondary Outcomes

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

Variation in androgen production

defined by the difference between the measurement at H8 and the measurement at H0 (4 hours before injection) of total testosterone and androstenedione.

Time frame: at 4 hours after injection

change in FSH levels

defined as the difference between the measurement at H8 and the measurement at H0 (4 hours prior to injection) of FSH

Time frame: at 4 hours post-injection

change in estradiol levels

defined as the difference between the measurement at H8 and the measurement at H0 (4 hours prior to injection) of estradiol

Time frame: at 4 hours post-injection

change in AMH levels

defined as the difference between the measurement at H8 and the measurement at H0 (4 hours prior to injection) of AMH.

Time frame: at 4 hours post-injection

Data from ClinicalTrials.gov

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