NCT05751252CompletedEarly phase 1
Sub-therapeutic GnRH- Antagonist Treatment to Rectify LH Pulsatility in Lean Women With PCOS.
Short-term GnRH- Antagonist Treatment to Lower LH Pulsatility in Women With PCOS Aiming to Improve Hormonal Functions
Source: ClinicalTrials.gov · Last updated 27 Apr 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 20 Feb 2023
- Start date
- 17 Apr 2024
- Primary completion date
- 9 Feb 2025
- Lead sponsor
- University Hospital, Lille
- NCT number
- NCT05751252
- EudraCT number
- 2023-000176-35
What you commit to
- Study type: Interventional · Early phase 1
- Participants enrolled: 20
- From 17 Apr 2024 to the primary completion date, 9 Feb 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- hormonal treatment or hormonal contraception
- Metformin treatment
- pregnant woman
- inability to understand the newsletter
Who the study is looking for
- 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
Age in the registry: 18 years to 35 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hôpital Jeanne de Flandre Coordinator of this site? Confirm its status | Lille | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.