Continuous Versus Cyclic Use of Oral Contraceptive Pills in Adolescents

July 17, 2008 updated by: The Hospital for Sick Children

Continuous Versus Cyclic Use of an Oral Contraceptive Pills in Adolescents

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

130

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • Recruiting
        • The Hospital for Sick Children
        • Contact:
        • Principal Investigator:
          • Lisa Allen, MD
        • Principal Investigator:
          • Sari Kives, MD
        • Sub-Investigator:
          • Rachel Spitzer, MD
        • Sub-Investigator:
          • Karen Leslie, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: 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.
Other Names:
  • Marvelon-21
Active Comparator: 2
Drug: 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 Names:
  • Marvelon-28

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary objective is to compare the compliance rates of adolescents who take OCPs continuously to those who take OCPs cyclically.
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
The number of girls who have positive pregnancy test results at 12 months
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hospital for Sick Children

Collaborators

The Physicians' Services Incorporated Foundation

Investigators

  • Principal Investigator: Lisa Allen, MD, The Hospital for Sick Children, Toronto Canada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Anticipated)

May 1, 2008

Study Completion (Anticipated)

May 1, 2009

Study Registration Dates

First Submitted

May 12, 2006

First Submitted That Met QC Criteria

May 12, 2006

First Posted (Estimate)

May 16, 2006

Study Record Updates

Last Update Posted (Estimate)

July 18, 2008

Last Update Submitted That Met QC Criteria

July 17, 2008

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1000008437

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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