NCT02841202

CompletedPhase 4

The Effect of Oral Contraceptive Pills On Eyes

Kayseri Education and Research Hospital Source

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Other study identifiers

Sponsor study identifier

2013/65

Study Type

interventional

Actual enrollment (reported)

40

Locations

0 countries

Sites

N/A

Timeline

Study Start

January 2014

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

December 2015

Actual (reported)

Study Completion

July 2016

Actual (reported)

Brief 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). 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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 40 participants
Study completion date: July 2016
Actual (reported)
Listed locations: 0 countries · 0 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
January 2014
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
December 2015
Actual (reported)
Study Completion
July 2016
Actual (reported)
First Submitted
July 14, 2016
Actual (reported)
First Posted
July 22, 2016
Actual (reported)

Last Updated: August 21, 2017
Status Verified: July 2016
Last Update Submitted: August 16, 2017

Conditions

Adverse Effect of Oral Contraceptives, Subsequent Encounter

Keywords

optical coherence tomographyoral contraceptive pills

Outcome Measures

Primary Outcomes (1)

Adverse Events on Eyes That Are Related to Treatment
one year

Study Arms (2)

oral contraceptive pills group

ACTIVE COMPARATOR

healthy women using oral contraceptive pills for only contraception for more than one year was called OCP group

Drug: oral contraceptive pills

control group

NO INTERVENTION

The second group was called control group consisting 20 healthy women and using no drug

Interventions

oral contraceptive pillsDrug

Also known as: yasmin

oral contraceptive pills group

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 48 Years

Sexfemale

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

All the participants in the study group were Caucasian origin and the ages of them ranged from 18 to 48 in the reproductive period

You may not qualify if:

Sponsors & Collaborators

Kayseri Education and Research Hospital
Governmentlead

MeSH Terms

Interventions

drospirenone and ethinyl estradiol combination

Study Officials

YUSUF MADENDAG
Kayseri Education and Research Hospital
PRINCIPAL INVESTIGATOR

Enrollment

40 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 4
Allocation: NON RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose: BASIC SCIENCE
Intervention Model: PARALLEL
Sponsor Type: OTHER GOV
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: obstetrics and gynecology

Study Record Dates

First Submitted

July 14, 2016

First Posted

July 22, 2016

Study Start

January 2014

Date type not reported

This date has not been verified as actual or estimated.

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.

Contact the study team to confirm eligibility.

Primary Completion

December 2015

Actual (reported)

Study Completion

July 2016

Actual (reported)

Last Updated

August 21, 2017

Record last verified: 2016-07

Source record

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Source: ClinicalTrials.gov.

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Registry identifier: NCT02841202
Data provider: ClinicalTrials.gov
Source updated: 2017-08-21
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:38:19 UTC

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

oral contraceptive pills group

control group

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

MeSH Terms

Interventions

Study Officials

Enrollment

Study Design

Study Record Dates

Source record