Women who choose to take birth control pills are currently instructed to begin taking the pills at the end of a menstrual cycle. This creates a window of time between when the woman is given the pills and when she begins taking them. Some women fail to begin taking the pills, placing them at increased risk of pregnancy. This study will evaluate a new approach to beginning birth control pills. Women will take the first pill in the doctor’s office rather than waiting until the next menstrual cycle.

Condition	Treatment or Intervention	Phase
Pregnancy Contraception	Behavior: Quick start oral contraceptive initiation	Phase IV

Further Study Details: 

Expected Total Enrollment:  2000

Despite the effectiveness of oral contraceptives, pregnancy rates are high among women who choose this method of birth control. These pregnancies occur due to incorrect use, premature discontinuation, and failure to begin taking oral contraceptives after they have been prescribed. As many as 25% of adolescents who seek oral contraceptives from family planning clinics never take the first pill. Failure to begin oral contraceptives may occur due to ambivalence, confusion about starting instructions, or intervening pregnancy. Conventional starting instructions for oral contraceptives require waiting until the next menstrual period; this may leave the woman at high risk of pregnancy. This trial will evaluate a "quick start" approach in which the woman swallows the first pill during the clinic visit under direct observation and then continues daily pill use without waiting for her next menses. The trial will determine whether immediate oral contraceptive initiation offers benefits compared to conventional starting approaches.

Participants in this study will be randomized to receive either the quick start or the standard starting approach. Participants will complete a questionnaire at study entry and Months 3 and 6. The main outcomes are 6-month oral contraceptive continuation rates and pregnancy rates.

Ages Eligible for Study:  up to  24 Years,  Genders Eligible for Study:  Female

Accepts Healthy Volunteers

Criteria

Inclusion Criteria

• Requests hormonal contraceptives as primary method of contraception
• Sexually active (intercourse within 30 days prior to study entry) or anticipating sexual activity within 30 days following study entry

Carolyn L. Westhoff, MD, MSc       clw@columbia.edu

Georgia
      Emory University School of Medicine, Atlanta,  Georgia,  30303,  United States; Recruiting
New York
      Mt. Sinai School of Medicine, New York,  New York,  10128,  United States; Recruiting
Texas
      University of Texas Southwestern Medical Center at Dallas, Dallas,  Texas,  75235,  United States; Recruiting

Study chairs or principal investigators

Carolyn L. Westhoff, MD, MSc,  Principal Investigator,  Columbia University   

Study ID Numbers:  HD42413
Record last reviewed:  September 2003
Last Updated:  October 13, 2004
Record first received:  September 10, 2003
ClinicalTrials.gov Identifier:  NCT00068848
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08