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Trial Title:
Sub-therapeutic GnRH- Antagonist Treatment to Rectify LH Pulsatility in Lean Women With PCOS.
NCT ID:
NCT05751252
Condition:
Polycystic Ovary Syndrome
Conditions: Official terms:
Polycystic Ovary Syndrome
Ganirelix
Conditions: Keywords:
PCOS
GnRH antagonist
LH
androgen
testosterone
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Ganirelix
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.
Arm group label:
0.025 mg
Intervention type:
Drug
Intervention name:
Ganirelix
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.
Arm group label:
0.0625 mg
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.
Criteria for 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
Gender:
Female
Gender based:
Yes
Gender description:
Patients followed in endocrine gynecology consultation in the Jeanne de Flandre
department
Minimum age:
18 Years
Maximum age:
35 Years
Healthy volunteers:
No
Start date:
July 2023
Completion date:
July 2024
Lead sponsor:
Agency:
University Hospital, Lille
Agency class:
Other
Source:
University Hospital, Lille
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05751252
