Continuous Versus Cyclic Use of Oral Contraceptive Pills in Adolescents

• Status: Unknown status
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Hospital for Sick Children
• Collaborator: The Physicians' Services Incorporated Foundation
• Treatments: Contraceptive Agents; Contraceptives, Oral; Contraceptives, Oral, Combined; Desogestrel; Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Ethinyl Estradiol; Polyestradiol phosphate

Criteria

Inclusion Criteria:

• Female

• Age 15 to 18

• Presenting to the Gynecology and Adolescent Medicine Clinic for contraception

Exclusion Criteria:

• 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)