Recruiting
Phase 3

Oral Contraceptive Pills

Sponsor:

The Hospital for Sick Children

Code:

NCT00326404

Conditions

Contraception

Eligibility Criteria

Sex: Female

Age: 15 - 18

Healthy Volunteers: Not accepted

Interventions

Desogestrel-Ethinyl Estradiol 21 tablets

Desogestrel-Ethinyl Estradiol 28 tablets

Study Details

Brief 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.

Conditions

Contraception

Study ID

NCT00326404

Start date

May, 2006

Status verified date

Jul, 2008

Completion date

May, 2009

Anticipated

Primary completion date

May, 2008

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 15 - 18

Healthy Volunteers: Not accepted

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 Design

Enrollment

130 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: 1

active comparator: 2

Interventions

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.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Lisa Allen, MD

416-813-6188lisa.allen@sickkids.ca

Locations

The Hospital for Sick Children

Recruiting

Toronto, Ontario, Canada, M5G 1X8

Contacts

Lisa Allen, MD

416 813 6188lisa.allen@sickkids.ca

Principal Investigator:

Lisa Allen, MD

More Information

Sponsor

The Hospital for Sick Children

Last update posted

Jul 18, 2008

Last verified

Jul, 2008

Keywords

  • Oral Contraceptives
  • Adolescents
  • Compliance

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Hospital for Sick Children on 2008-07-18.