Combined Oral Contraceptives IntakePILURETNCT03964636
Contraceptive Pills and Retinal Vascularization
An observational study of Combined Oral Contraceptives Intake, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
The main hypothesis is the taking of combined 1st and 2nd generation or 3rd and 4th generation oral contraceptives is associated with a change in retinal micro-vascularization compared to the absence of combined oral contraceptive intake. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Combined Oral Contraceptives Intake
- What is being tested?
- OCT-A (optical coherence tomography)
- How many people
- 51 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jul 2019to 1 Dec 2022
- Phase
- Observational
- 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 18 years and older
- Women only
- Adult, Older adult
Study population: Women of chilbearing age presenting to an ophthalmologic consultation at the Foundation Rothschild will be included in one of the 3 groups: no contraceptive intake, combined 1st/2nd generation oral contraceptives and 3rd/4th generation combined oral contraceptives, if they meet the inclusion and non-inclusion criteria
Who may be able to join
- for the control group : No Estro-progestin contraceptive treatment (oral, transdermal) for at least 6 months
- for the cases under combined 1st and 2nd generation pills : Estro-progestin contraceptive treatment for at least 6 months
- for the cases under combined 3rd and 2th generation pills: Estro-progestin contraceptive treatment for at least 6 months
Who cannot join
- Menopausal woman
- Ametropia greater than + 3 hyperopia diopters or-3 myopia diopters
- Astigmatism greater than 2 dioptres
- Smoking patient (cigarette or e-cigarette)
- Caffeine intake within 2 hours prior to the OCT-A exam
- Any known retinal pathology
- Antecedent of deep vein thrombosis or deep arterial thrombosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Contraceptive Pills and Retinal Vascularization (Piluret)
The main hypothesis is the taking of combined 1st and 2nd generation or 3rd and 4th generation oral contraceptives is associated with a change in retinal micro-vascularization compared to the absence of combined oral contraceptive intake.
Women of childbearing age will be recruited during their ophthalmologic consultation at the Rothschild Foundation, an OCT-A will be realized and data relating to their medical and ophthalmologic history and their oestro-progestative contraceptive intake will be collected.
The objective is to find an association between retinal vascular density and combined oral contraceptives intake.
- Conditions
- Combined Oral Contraceptives Intake
- Being tested
- OCT-A (optical coherence tomography)
- Keywords
- OCT-A, combined oral contraceptives
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCT-A (optical coherence tomography)Diagnostic test
Included patients will have an OCT-A and will be questioned about their medical and ophthalmologic history, and their oestro-progestative contraceptive intake.
| Study group | Role | What they receive |
|---|---|---|
| no contraceptive intake | Not described Receives: Diagnostic Test: OCT-A (optical coherence tomography) | |
| combined 1st/2nd generation oral contraceptives intake | Not described Receives: Diagnostic Test: OCT-A (optical coherence tomography) | |
| 3rd/4th generation combined oral contraceptives intake | Not described Receives: Diagnostic Test: OCT-A (optical coherence tomography) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Density of retinal vascular Plexus (quantitative variable expressed as a percentage) using OCT-A.
Measured: At the inclusion consultation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2019
- Study start17 Jul 2019
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Combined Oral Contraceptives IntakeStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03964636
- Sponsor's protocol ID
- VVR_2019_6
- Acronym
- PILURET
- Status last verified
- Feb 2023
- First submitted
- 24 May 2019
- Last updated
- 17 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contraceptive Pills and Retinal Vascularization (Piluret)
- ClinicalTrials.gov ID
- NCT03964636
- Acronym / sponsor ID
- PILURET / VVR_2019_6
- Conditions
- Combined Oral Contraceptives Intake
- Keywords
- OCT-A, combined oral contraceptives
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 17 Jul 2019 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 28 May 2019 (actual)
- 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 main hypothesis is the taking of combined 1st and 2nd generation or 3rd and 4th generation oral contraceptives is associated with a change in retinal micro-vascularization compared to the absence of combined oral contraceptive intake.
Women of childbearing age will be recruited during their ophthalmologic consultation at the Rothschild Foundation, an OCT-A will be realized and data relating to their medical and ophthalmologic history and their oestro-progestative contraceptive intake will be collected.
The objective is to find an association between retinal vascular density and combined oral contraceptives intake.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| no contraceptive intake | – | Diagnostic Test: OCT-A (optical coherence tomography) |
| combined 1st/2nd generation oral contraceptives intake | – | Diagnostic Test: OCT-A (optical coherence tomography) |
| 3rd/4th generation combined oral contraceptives intake | – | Diagnostic Test: OCT-A (optical coherence tomography) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Women of chilbearing age presenting to an ophthalmologic consultation at the Foundation Rothschild will be included in one of the 3 groups: no contraceptive intake, combined 1st/2nd generation oral contraceptives and 3rd/4th generation combined oral contraceptives, if they meet the inclusion and non-inclusion criteria
Key inclusion criteria (3 listed)
- for the control group : No Estro-progestin contraceptive treatment (oral, transdermal) for at least 6 months
- for the cases under combined 1st and 2nd generation pills : Estro-progestin contraceptive treatment for at least 6 months
- for the cases under combined 3rd and 2th generation pills: Estro-progestin contraceptive treatment for at least 6 months
Key exclusion criteria (7 listed)
- Menopausal woman
- Ametropia greater than + 3 hyperopia diopters or-3 myopia diopters
- Astigmatism greater than 2 dioptres
- Smoking patient (cigarette or e-cigarette)
- Caffeine intake within 2 hours prior to the OCT-A exam
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 |
|---|---|---|
| OCT-A (optical coherence tomography)Included patients will have an OCT-A and will be questioned about their medical and ophthalmologic history, and their oestro-progestative contraceptive intake. | Diagnostic test | 3rd/4th generation combined oral contraceptives intake, combined 1st/2nd generation oral contraceptives intake, no contraceptive intake |
Primary outcome
Density of retinal vascular Plexus (quantitative variable expressed as a percentage) using OCT-A.
Time frame: At the inclusion consultation
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 17 Feb 2023.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Combined Oral Contraceptives Intake, run by Fondation Ophtalmologique Adolphe de Rothschild 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 3 inclusion and 7 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 17 Feb 2023. 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?
Density of retinal vascular Plexus (quantitative variable expressed as a percentage) using OCT-A. (time frame: At the inclusion consultation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Feb 2023.