Status:
UNKNOWN
Continuous Versus Cyclic Use of Oral Contraceptive Pills in Adolescents
Lead Sponsor:
The Hospital for Sick Children
Collaborating Sponsors:
The Physicians' Services Incorporated Foundation
Conditions:
Contraception
Eligibility:
FEMALE
15-18 years
Phase:
PHASE3
Brief Summary
The primary purpose of this study is to compare the compliance rates of adolescents who take oral contraceptives (OCPs) continuously to those who take OCPs cyclically.
Detailed Description
Oral contraceptive pills have traditionally been prescribed in a cyclical manner, where there are 21-24 days of active pills and 4-7 days of placebo pills or a pill-free interval, creating a 28-day cy...
Eligibility Criteria
Inclusion
- Female
- Age 15 to 18
- Presenting to the Gynecology and Adolescent Medicine Clinic for contraception
Exclusion
- Prior use of the study medication with no improvement in symptoms
- Any medical condition that indicates continuous OCPs (i.e. acute menorrhagia, dysmenorrhea that did not previously respond to cyclical OCP use)
- Personal history of or current thromboembolic disorder
- First-degree relative(s) with thromboembolic disorder
- Cerebrovascular disease
- Coronary artery disease
- Cardiac valvular disease
- Hypertension (systolic blood pressure \> 160 mmHg or diastolic \> 100 mmHG)
- Diabetes with retinopathy/neuromyopathy/nephropathy)
- Breast cancer
- Endometrial cancer
- Undiagnosed abnormal uterine bleeding
- Cholestatic jaundice of pregnancy
- Hepatic tumor
- Known or suspected pregnancy
- Less than 6 months postpartum if breastfeeding
- Classic migraine with aura or any other neurological signs
- Gallbladder disease
- Taking any medications known to affect the efficacy of OCPs (i.e. phenytoin, phenobarbital, primidone, carbamazepine, griseofulvin, rifampin)
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2009
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT00326404
Start Date
May 1 2006
End Date
May 1 2009
Last Update
July 18 2008
Active Locations (1)
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1
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8