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

Polycystic Ovary Syndrome Clinical Trial

— SOPKGANI  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05751252
• Other study ID #: 2022_0016
• Secondary ID: 2023-000176-35
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: July 2023
• Est. completion date: July 2024

Study information

• Verified date: February 2023
• Source: University Hospital, Lille
• Contact: Sophie Catteau-Jonard, MD,PhD
• Phone: 0320445962
• Email: sophie.catteau[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

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

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome

Intervention

Drug:
• Ganirelix
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.
• Ganirelix
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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.	at 4 hours after injection
Secondary	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	at 4 hours post-injection
Secondary	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	at 4 hours post-injection
Secondary	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.	at 4 hours post-injection