Continuous Versus Cyclic Use of Oral Contraceptive Pills in Adolescents
Information source: The Hospital for Sick Children
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Contraception
Intervention: Desogestrel-Ethinyl Estradiol 21 tablets (Drug); Desogestrel-Ethinyl Estradiol 28 tablets (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: The Hospital for Sick Children Official(s) and/or principal investigator(s):
Lisa Allen, MD, Principal Investigator, Affiliation: The Hospital for Sick Children, Toronto Canada
Overall contact:
Lisa Allen, MD, Phone: 416-813-6188, Email: lisa.allen@sickkids.ca
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.
Clinical Details
Official title: Continuous Versus Cyclic Use of an Oral Contraceptive Pills in Adolescents
Study design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: The primary objective is to compare the compliance rates of adolescents who take OCPs continuously to those who take OCPs cyclically.
Secondary outcome: The number of girls who have positive pregnancy test results at 12 months
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 cycle. It has now been proven that as long as a woman has both estrogen and
progesterone, her uterine lining is protected and is thin. To that effect, a new OCP
(Seasonale®, Barr Laboratories, Pomona, NY) has been packaged in the United States that
combines 84 days of active pills with 7 days of placebo pills. This allows a withdrawal bleed
every 3 months.
Like in adult women, OCPs are the most popular form of birth control and cycle control in
adolescents. But, for a variety of reasons, adolescents tend to have poorer compliance when
taking OCPs. Adult women tend to be noncompliant about 6% of the time, but, by the end of one
year, adolescents have a non-compliance rate of 34-66%.
There have been few studies that even describe improved compliance and decreased ovarian
follicular development in women who take OCPs continuously, which could be beneficial in
decreasing the rate of adolescent pregnancy. The majority of the studies looking at
continuous use of OCPs have been performed in adult women. At present, there has been only
one article that has addressed the use of continuous OCPs in adolescents. Sucato and Gold
discussed the indications of continuous use of OCPs, how to prescribe them, and what type of
progestin to use; but they did not specifically examine compliance or the safety and efficacy
of continuous OCPs in adolescents. We plan to evaluate these issues in our study.
Eligibility
Minimum age: 15 Years.
Maximum age: 18 Years.
Gender(s): Female.
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)
Locations and Contacts
Lisa Allen, MD, Phone: 416-813-6188, Email: lisa.allen@sickkids.ca
The Hospital for Sick Children, Toronto, Ontario M5G 1X8, Canada; Recruiting
Lisa Allen, MD, Phone: 416 813 6188, Email: lisa.allen@sickkids.ca
Lisa Allen, MD, Principal Investigator
Sari Kives, MD, Principal Investigator
Rachel Spitzer, MD, Sub-Investigator
Karen Leslie, MD, Sub-Investigator
Additional Information
Starting date: May 2006
Ending date: May 2009
Last updated: July 17, 2008
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