Status
Completed
Phase
Early Phase 1
Enrollment
20
Locations
1
Results
Not posted
Publications
0
Study 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.
Interventions
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.
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.
Timeline
First posted
Mar 2, 2023
Study start
Apr 17, 2024
Primary completion
Feb 9, 2025
Study completion
Feb 9, 2025
Results posted
Not reported
Registry updated
Apr 27, 2025
Outcomes
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.
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
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.
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
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
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.
Eligibility
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
Study locations
France. Showing up to 24 locations stored in the fast local snapshot.
Hôpital Jeanne de Flandre
Lille, France
Publications
No PMID-linked publications were present in this registry snapshot.
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