Functional Study of the Hypothalamus in Magnetic Resonance Imaging (MRI) in Polycystic Ovary Syndrome (PCOS)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-26

Study Completion Date

2022-04-15

Brief Summary

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The aim to evaluate whether activation of the hypothalamic-pituitary-gonadal axis in PCOS is associated with transient microstructural and metabolic changes in the female hypothalamus using MRI approaches to assess water diffusion and measure proton magnetic resonance spectra.

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Detailed Description

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Conditions

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Polycystic Ovary Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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PCOS women

26 PCOS women who receive consultation for hyperandrogenism needing treatment with Cyproterone Acetate + estradiol will be recruited.

Group Type OTHER

Cyproterone Acetate + estradiol

Intervention Type DRUG

PCOS will receive:

50mg cyproterone acetate (Androcur®) in combination with p.o. 2mg estradiol daily

Healthy volunteers

26 Healthy volunteers subjects who receive consultation contemplating oral contraceptives (Levonorgestrel, Ethinyl Estradiol 0.1-0.02Mg Oral Tablet ) will be recruited.

Group Type OTHER

Levonorgestrel, Ethinyl Estradiol 0.1-0.02Mg Oral Tablet

Intervention Type DRUG

Healthy volunteers receive combined oral contraceptive (COC) consisting 0.02 mg ethinylestradiol and 0.1mg of progestins (Leeloo Gé®)

Interventions

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Cyproterone Acetate + estradiol

PCOS will receive:

50mg cyproterone acetate (Androcur®) in combination with p.o. 2mg estradiol daily

Intervention Type DRUG

Levonorgestrel, Ethinyl Estradiol 0.1-0.02Mg Oral Tablet

Healthy volunteers receive combined oral contraceptive (COC) consisting 0.02 mg ethinylestradiol and 0.1mg of progestins (Leeloo Gé®)

Intervention Type DRUG

Other Intervention Names

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Androcur, Provames Leeloo Gé®

Eligibility Criteria

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Inclusion Criteria

For all subjects

* Aged from 19 to 30 years
* Body mass index : 18-25
* Informed consent before inclusion
* Do not smoke the 3 days before the MRI

For Healthy volunteers subjects :

* Regular cycles (between 25 and 35 days) AND ovulatory.
* No signs of hyperandrogenism.
* Subjects desirous of taking oral contraceptives (estrogen/progestin combination).
* For the realization of the 2nd MRI: to be during the 3rd month of a treatment well followed by oestro-progestative monophasic minidose to 0,02mg of Ethinyl-oestradiol / 0,1mg Levonorgestrel.

PCOS women:

* PCOS defined by Rotterdam criteria
* Needing a treatment with cyproterone acetate
* To carry out the 2nd MRI: to be in progress during the 3rd month of a treatment well followed by 50 mg of Cyproterone acetate in association with 2mg / day of natural estradiol.

Exclusion Criteria

* Hormone treatment within 3 months prior to inclusion (including birth control pill )
* On-going pregnancy (determined before each MRI scan visit)
* Claustrophobia
* Any metal or foreign implants (e.g., aneurysm clips, ear implants, heart pacemakers or defibrillators)
* Diabetes or known dysthyroidism.
* Current substance abuse (including smoking more than 5 cigarettes/day; determined using drug screening at the screening visit)
* Pregnancy or breastfeeding the last 3 months.
* Practice of intense physical exercise (ex jogging\> 10km) the day before the MRI.
* Person incapable of consenting, or enjoying legal protection (guardianship / curatorship).
* Unability to understand the treatment protocol

Minimum Eligible Age

19 Years

Maximum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes