Back to resultsSub-therapeutic GnRH- Antagonist Treatment to Rectify LH Pulsatility in Lean Women With PCOS. (SOPKGANI)
Primary Purpose
Polycystic Ovary Syndrome
Status
Not yet recruiting
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Ganirelix
Ganirelix
Sponsored by
About this trial
This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring PCOS, GnRH antagonist, LH, androgen, testosterone
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
0.0625 mg
0.025 mg
Arm Description
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
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Variation in LH secretion amplitude before and after Ganirelix* injection (area under the curve)
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.
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
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
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.
Full Information
NCT ID
NCT05751252
First Posted
February 20, 2023
Last Updated
February 20, 2023
Sponsor
University Hospital, Lille
1. Study Identification
Unique Protocol Identification Number
NCT05751252
Brief Title
Sub-therapeutic GnRH- Antagonist Treatment to Rectify LH Pulsatility in Lean Women With PCOS.
Acronym
SOPKGANI
Official Title
Short-term GnRH- Antagonist Treatment to Lower LH Pulsatility in Women With PCOS Aiming to Improve Hormonal Functions
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2023 (Anticipated)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
PCOS, GnRH antagonist, LH, androgen, testosterone
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
0.0625 mg
Arm Type
Experimental
Arm Description
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
Arm Title
0.025 mg
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ganirelix
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Ganirelix
Intervention Description
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.
Primary Outcome Measure Information:
Title
Serum LH level
Description
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 Outcome Measure Information:
Title
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
Title
Variation in androgen production
Description
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
Title
change in FSH levels
Description
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
Title
change in estradiol levels
Description
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
Title
change in AMH levels
Description
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
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Patients followed in endocrine gynecology consultation in the Jeanne de Flandre department
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sophie Catteau-Jonard, MD,PhD
Phone
0320445962
Email
sophie.catteau@chru-lille.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sophie Catteau-Jonard, MD,PhD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Sub-therapeutic GnRH- Antagonist Treatment to Rectify LH Pulsatility in Lean Women With PCOS.
We'll reach out to this number within 24 hrs