Polycystic Ovary SyndromeMRI-PCOSNCT03043924
Functional Study of the Hypothalamus in Magnetic Resonance Imaging (MRI) in Polycystic Ovary Syndrome (PCOS)
A study testing Cyproterone Acetate + estradiol and Levonorgestrel, Ethinyl Estradiol 0.1-0.02Mg Oral Tablet in people with Polycystic Ovary Syndrome, run by University Hospital, Lille at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Cyproterone Acetate + estradiol and Levonorgestrel, Ethinyl Estradiol 0.1-0.02Mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteFrance
- Study dates
- 26 Sep 2017to 15 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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 :
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- 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.
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Functional Study of the Hypothalamus in High-resolution Magnetic Resonance Imaging (MRI) in Women With Polycystic Ovary Syndrome (PCOS): a Comparative Study
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.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Cyproterone Acetate + estradiol, Levonorgestrel, Ethinyl Estradiol 0.1-0.02Mg Oral Tablet
- Keywords
- hypothalamus, Diffusion Magnetic Resonance Imaging, Magnetic Resonance Spectroscopy
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyproterone Acetate + estradiolDrug
Also called Androcur, Provames
PCOS will receive:
50mg cyproterone acetate (Androcur®) in combination with p.o. 2mg estradiol daily
Levonorgestrel, Ethinyl Estradiol 0.1-0.02Mg Oral TabletDrug
Also called Leeloo Gé®
Healthy volunteers receive combined oral contraceptive (COC) consisting 0.02 mg ethinylestradiol and 0.1mg of progestins (Leeloo Gé®)
| Study group | Role | What they receive |
|---|---|---|
| PCOS women | Other | 26 PCOS women who receive consultation for hyperandrogenism needing treatment with Cyproterone Acetate + estradiol will be recruited. Receives: Drug: Cyproterone Acetate + estradiol |
| Healthy volunteers | Other | 26 Healthy volunteers subjects who receive consultation contemplating oral contraceptives (Levonorgestrel, Ethinyl Estradiol 0.1-0.02Mg Oral Tablet ) will be recruited. Receives: Drug: Levonorgestrel, Ethinyl Estradiol 0.1-0.02Mg Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Apparent Diffusion Coefficient (ADC)
The change in the ADC will be analyzed in healthy volunteers and PCOS women before starting the oral contraceptives, and next during the third sequence of treatment.
Measured: Baseline and 3 months after treatment start
Secondary outcomes (5)
Change in the metabolite concentrations
The change in the metabolite concentrations will be analyzed in the two groups before starting the oral contraceptives, and next during the third sequence of treatment.
Measured: Baseline and 3 months after treatment start
Correlation coefficient (Spearman or Pearson) between the ADC and serum hormonal levels (FSH,luteinizing hormone,oestradiol, AMH)
The correlation between ADC and hormonal levels in the two groups will be analysed before starting the contraceptive treatment and during the third processing sequence.
Measured: Baseline and 3 months after treatment start
Correlation coefficient (Spearman or Pearson) between the metabolite concentrations and serum hormonal levels (FSH, luteinizing hormone, oestradiol, AMH)
The correlation between metabolite concentrations and hormonal levels in the two groups will be analysed before starting the contraceptive treatment and during the third processing sequence.
Measured: Baseline and 3 months after treatment start
Plasma GnRH concentration before and after treatment (PCOS patient and control group)
Measured: Baseline and 3 months after treatment start
Correlation between brain metabolite concentrations and plasma GnRH concentration before and after contraception.
Measured: Baseline and 3 months after treatment start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2017 (estimated)
- Study start26 Sep 2017
- Primary completion15 Apr 2022
- Study completion15 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Agency, France
- Responsible party
- Sponsor
- Investigators
- Didier Dewailly, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03043924
- Sponsor's protocol ID
- 2016_22
- Other IDs
- 2016-A01391-50
- Acronym
- MRI-PCOS
- Status last verified
- Dec 2025
- First submitted
- 31 Jan 2017
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barbotin AL, Mimouni NEH, Kuchcinski G, Lopes R, Viard R, Rasika S, Mazur D, Silva MSB, Simon V, Boursier A, Pruvo JP, Yu Q, Candlish M, Boehm U, Bello FD, Medana C, Pigny P, Dewailly D, Prevot V, Catteau-Jonard S, Giacobini P. Hypothalamic neuroglial plasticity is regulated by anti-Mullerian hormone and disrupted in polycystic ovary syndrome. EBioMedicine. 2023 Apr;90:104535. doi: 10.1016/j.ebiom.2023.104535. Epub 2023 Mar 29.
PubMed 37001236
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Study of the Hypothalamus in High-resolution Magnetic Resonance Imaging (MRI) in Women With Polycystic Ovary Syndrome (PCOS): a Comparative Study
- ClinicalTrials.gov ID
- NCT03043924
- Acronym / sponsor ID
- MRI-PCOS / 2016_22
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- hypothalamus, Diffusion Magnetic Resonance Imaging, Magnetic Resonance Spectroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- National Research Agency, France
- Study start
- 26 Sep 2017 (actual)
- Primary completion
- 15 Apr 2022 (actual)
- Study completion
- 15 Apr 2022 (actual)
- First posted
- 6 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCOS women | Other | Drug: Cyproterone Acetate + estradiol26 PCOS women who receive consultation for hyperandrogenism needing treatment with Cyproterone Acetate + estradiol will be recruited. |
| Healthy volunteers | Other | Drug: Levonorgestrel, Ethinyl Estradiol 0.1-0.02Mg Oral Tablet26 Healthy volunteers subjects who receive consultation contemplating oral contraceptives (Levonorgestrel, Ethinyl Estradiol 0.1-0.02Mg Oral Tablet ) will be recruited. |
Who may qualify
- Ages
- 19 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cyproterone Acetate + estradiolAlso: Androcur, ProvamesPCOS will receive: 50mg cyproterone acetate (Androcur®) in combination with p.o. 2mg estradiol daily | Drug | PCOS women |
| Levonorgestrel, Ethinyl Estradiol 0.1-0.02Mg Oral TabletAlso: Leeloo Gé®Healthy volunteers receive combined oral contraceptive (COC) consisting 0.02 mg ethinylestradiol and 0.1mg of progestins (Leeloo Gé®) | Drug | Healthy volunteers |
Primary outcome
Change in the Apparent Diffusion Coefficient (ADC)
Time frame: Baseline and 3 months after treatment start
The change in the ADC will be analyzed in healthy volunteers and PCOS women before starting the oral contraceptives, and next during the third sequence of treatment.
5 secondary outcomes
Change in the metabolite concentrations
Time frame: Baseline and 3 months after treatment start
Correlation coefficient (Spearman or Pearson) between the ADC and serum hormonal levels (FSH,luteinizing hormone,oestradiol, AMH)
Time frame: Baseline and 3 months after treatment start
Correlation coefficient (Spearman or Pearson) between the metabolite concentrations and serum hormonal levels (FSH, luteinizing hormone, oestradiol, AMH)
Time frame: Baseline and 3 months after treatment start
Plasma GnRH concentration before and after treatment (PCOS patient and control group)
Time frame: Baseline and 3 months after treatment start
Correlation between brain metabolite concentrations and plasma GnRH concentration before and after contraception.
Time frame: Baseline and 3 months after treatment start
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Results publication: PubMed 37001236Barbotin AL, Mimouni NEH, Kuchcinski G, Lopes R, Viard R, Rasika S, Mazur D, Silva MSB, Simon V, Boursier A, Pruvo JP, Yu Q, Candlish M, Boehm U, Bello FD, Medana C, Pigny P, Dewailly D, Prevot V, Catteau-Jonard S, Giacobini P. Hypothalamic neuroglial plasticity is regulated by anti-Mullerian hormone and disrupted in polycystic ovary syndrome. EBioMedicine. 2023 Apr;90:104535. doi: 10.1016/j.ebiom.2023.104535. Epub 2023 Mar 29.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Didier Dewailly, MD,PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cyproterone Acetate + estradiol and Levonorgestrel, Ethinyl Estradiol 0.1-0.02Mg Oral Tablet in people with Polycystic Ovary Syndrome, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Apparent Diffusion Coefficient (ADC) (time frame: Baseline and 3 months after treatment start). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03043924, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.