Continuous Versus Cyclic Use of Oral Contraceptive Pills in Adolescents
NCT ID: NCT00326404
Last Updated: 2008-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
130 participants
INTERVENTIONAL
2006-05-31
2009-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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1
Desogestrel-Ethinyl Estradiol 21 tablets
The participants in the continuous study arm will be given 4 packs of Marvelon-21, so that they can take the pills continuously for 84 days followed by no medication for 7 days. During these 7 days, the participant will have a withdrawal bleed. This sequence is repeated by the participant for a total of 12 months. Each patient in the continuous arm will have 4 withdrawal bleeds per year.
2
Desogestrel-Ethinyl Estradiol 28 tablets
The participants in the cyclical arm of the study will be given 3 packs of Marvelon-28 and asked to take all the pills in the packet, including the placebo pills. During the week of placebo pills, these participants will have a withdrawal bleed. Each patient in the cyclical arm will have 12 withdrawal bleeds per year. The duration of study drug treatment for both arms is 12 months.
Interventions
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Desogestrel-Ethinyl Estradiol 21 tablets
The participants in the continuous study arm will be given 4 packs of Marvelon-21, so that they can take the pills continuously for 84 days followed by no medication for 7 days. During these 7 days, the participant will have a withdrawal bleed. This sequence is repeated by the participant for a total of 12 months. Each patient in the continuous arm will have 4 withdrawal bleeds per year.
Desogestrel-Ethinyl Estradiol 28 tablets
The participants in the cyclical arm of the study will be given 3 packs of Marvelon-28 and asked to take all the pills in the packet, including the placebo pills. During the week of placebo pills, these participants will have a withdrawal bleed. Each patient in the cyclical arm will have 12 withdrawal bleeds per year. The duration of study drug treatment for both arms is 12 months.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 15 to 18
* Presenting to the Gynecology and Adolescent Medicine Clinic for contraception
Exclusion Criteria
* 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)
15 Years
18 Years
FEMALE
No
Sponsors
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The Physicians' Services Incorporated Foundation
OTHER
The Hospital for Sick Children
OTHER
Responsible Party
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The Hospital for Sick Children
Principal Investigators
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Lisa Allen, MD
Role: PRINCIPAL_INVESTIGATOR
The Hospital for Sick Children, Toronto Canada
Locations
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The Hospital for Sick Children
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Lisa Allen, MD
Role: primary
References
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Walpole B, Dettmer E, Morrongiello B, McCrindle B, Hamilton J. Motivational interviewing as an intervention to increase adolescent self-efficacy and promote weight loss: methodology and design. BMC Public Health. 2011 Jun 10;11:459. doi: 10.1186/1471-2458-11-459.
Other Identifiers
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1000008437
Identifier Type: -
Identifier Source: org_study_id