Continuous Versus Cyclic Use of Oral Contraceptive Pills in Adolescents
Recruitment status was: Recruiting
|Contraception||Drug: Desogestrel-Ethinyl Estradiol 21 tablets Drug: Desogestrel-Ethinyl Estradiol 28 tablets||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
|Official Title:||Continuous Versus Cyclic Use of an Oral Contraceptive Pills in Adolescents|
- 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 ]
- The number of girls who have positive pregnancy test results at 12 months [ Time Frame: 1 year ]
|Study Start Date:||May 2006|
|Estimated Study Completion Date:||May 2009|
|Estimated Primary Completion Date:||May 2008 (Final data collection date for primary outcome measure)|
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 Name: 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 Name: Marvelon-28
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00326404
|Contact: Lisa Allen, MDemail@example.com|
|The Hospital for Sick Children||Recruiting|
|Toronto, Ontario, Canada, M5G 1X8|
|Contact: Lisa Allen, MD 416 813 6188 firstname.lastname@example.org|
|Principal Investigator: Lisa Allen, MD|
|Principal Investigator: Sari Kives, MD|
|Sub-Investigator: Rachel Spitzer, MD|
|Sub-Investigator: Karen Leslie, MD|
|Principal Investigator:||Lisa Allen, MD||The Hospital for Sick Children, Toronto Canada|