Adverse Effect of Oral Contraceptives, Subsequent EncounterPhase 4NCT02841202
The Effect of Oral Contraceptive Pills On Eyes
A Phase 4 study testing oral contraceptive pills in people with Adverse Effect of Oral Contraceptives, Subsequent Encounter, run by Kayseri Education and Research Hospital.
Trial summary
The investigators aimed to evaluate the effect of oral contraceptive pills(OCP) on macula, retinal nerve fiber layer and choroid thickness by using Optical Coherence Tomography (OCT). Read more about this study
- Who is it for?
- Ages 18 to 48 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Adverse Effect of Oral Contraceptives, Subsequent Encounter
- What is being tested?
- oral contraceptive pills
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Jul 2016
- Phase
- Phase 4
- 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 to 48 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- All the participants in the study group were Caucasian origin and the ages of them ranged from 18 to 48 in the reproductive period
Who cannot join
- None of the women in the study was pregnant. Women who reported histories of any medical problems such as thyroid disorders, hypertension, thromboembolic disease, diabetes mellitus, cardiovascular events, Cushing disease, positive malignancy, congenital adrenal hyperplasia, liver disease, psychotic disorders and neither did they use antidepressants nor steroidal hormone drugs and mood stabilizers (lithium, valproic acid, cocaine, antiandrogens, and insulin sensitizers, etc) were excluded from the study. Subjects were also excluded if they used caffeine or tobacco. The investigators also excluded from the study those women who had ocular surgery, ocular trauma or any ocular diseases such as glaucoma, cystoid macular edema, macular degeneration, optic atrophy, intraocular pressure 421 mmHg, cataract, best corrected visual acuity worse than 20/30, high spherical4± 3 dioptre or cylindrical42 dioptre refractive errors and uveitis at the time of OCT measurement.
About this study
Official title: The Effect of Oral Contraceptive Pills On Macula, Retinal Nerve Fiber Layer and Choroid Thickness
The investigators aimed to evaluate the effect of oral contraceptive pills(OCP) on macula, retinal nerve fiber layer and choroid thickness by using Optical Coherence Tomography (OCT). The present clinical study is the first research reported in the literature which is investigating the posterior ocular segment changes in women using OCP by using OCT.
Read the detailed description
Spectral-domain optical coherence tomography (OCT) which is used to evaluate retina both qualitatively and qualitatively is a non invasive process. And also OCT makes it possible to perform retinal exams repeatedly without eye drops and dilatation.
- Being tested
- oral contraceptive pills
- Keywords
- optical coherence tomography, oral contraceptive pills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral contraceptive pillsDrug
Also called yasmin
| Study group | Role | What they receive |
|---|---|---|
| oral contraceptive pills group | Active comparator | healthy women using oral contraceptive pills for only contraception for more than one year was called OCP group Receives: Drug: oral contraceptive pills |
| control group | No intervention | The second group was called control group consisting 20 healthy women and using no drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events on Eyes That Are Related to Treatment
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2016 (estimated)
- Study startJan 2014
- Primary completionDec 2015
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse Effect of Oral Contraceptives, Subsequent EncounterStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kayseri Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yusuf MADENDAG, Kayseri Education and Research Hospital
- Investigators
- YUSUF MADENDAG, Principal investigator, Kayseri Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02841202
- Sponsor's protocol ID
- 2013/65
- Status last verified
- Jul 2016
- First submitted
- 14 Jul 2016
- Last updated
- 21 Aug 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oral Contraceptive Pills On Macula, Retinal Nerve Fiber Layer and Choroid Thickness
- ClinicalTrials.gov ID
- NCT02841202
- Acronym / sponsor ID
- 2013/65
- Keywords
- optical coherence tomography, oral contraceptive pills
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kayseri Education and Research HospitalOther government
- Study start
- Jan 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 22 Jul 2016 (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 investigators aimed to evaluate the effect of oral contraceptive pills(OCP) on macula, retinal nerve fiber layer and choroid thickness by using Optical Coherence Tomography (OCT). The present clinical study is the first research reported in the literature which is investigating the posterior ocular segment changes in women using OCP by using OCT.
Detailed description
Spectral-domain optical coherence tomography (OCT) which is used to evaluate retina both qualitatively and qualitatively is a non invasive process. And also OCT makes it possible to perform retinal exams repeatedly without eye drops and dilatation.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oral contraceptive pills group | Active comparator | Drug: oral contraceptive pillshealthy women using oral contraceptive pills for only contraception for more than one year was called OCP group |
| control group | No intervention | –The second group was called control group consisting 20 healthy women and using no drug |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All the participants in the study group were Caucasian origin and the ages of them ranged from 18 to 48 in the reproductive period
Key exclusion criteria (1 listed)
- None of the women in the study was pregnant. Women who reported histories of any medical problems such as thyroid disorders, hypertension, thromboembolic disease, diabetes mellitus, cardiovascular events, Cushing disease, positive malignancy, congenital adrenal hyperplasia, liver disease, psychotic disorders and neither did they use antidepressants nor steroidal hormone drugs and mood stabilizers (lithium, valproic acid, cocaine, antiandrogens, and insulin sensitizers, etc) were excluded from the study. Subjects were also excluded if they used caffeine or tobacco. The investigators also excluded from the study those women who had ocular surgery, ocular trauma or any ocular diseases such as glaucoma, cystoid macular edema, macular degeneration, optic atrophy, intraocular pressure 421 mmHg, cataract, best corrected visual acuity worse than 20/30, high spherical4± 3 dioptre or cylindrical42 dioptre refractive errors and uveitis at the time of OCT measurement.
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 |
|---|---|---|
| oral contraceptive pillsAlso: yasmin | Drug | oral contraceptive pills group |
Primary outcome
Adverse Events on Eyes That Are Related to Treatment
Time frame: one year
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 21 Aug 2017.
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.
YUSUF MADENDAG principal investigator
Kayseri Education and Research Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing oral contraceptive pills in people with Adverse Effect of Oral Contraceptives, Subsequent Encounter, run by Kayseri Education and Research Hospital.
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 1 inclusion and 1 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 21 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Adverse Events on Eyes That Are Related to Treatment (time frame: one year). 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 21 Aug 2017.