NCT00068848

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for phase_4 pregnancy

Timeline
Completed

Started Feb 2003

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 11, 2003

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
Last Updated

April 10, 2007

Status Verified

April 1, 2007

First QC Date

September 10, 2003

Last Update Submit

April 9, 2007

Conditions

PregnancyContraception

Keywords

Oral ContraceptivesInitiationContinuation

Interventions

Quick start oral contraceptive initiationBEHAVIORAL

Eligibility Criteria

AgeUp to 24 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Emory University School of Medicine

Atlanta, Georgia, 30303, United States

Location

Mt. Sinai School of Medicine

New York, New York, 10128, United States

Location

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75235, United States

Location

Related Publications (1)

  • Westhoff C, Heartwell S, Edwards S, Zieman M, Cushman L, Robilotto C, Stuart G, Morroni C, Kalmuss D. Initiation of oral contraceptives using a quick start compared with a conventional start: a randomized controlled trial. Obstet Gynecol. 2007 Jun;109(6):1270-6. doi: 10.1097/01.AOG.0000264550.41242.f2.

    PMID: 17540797DERIVED

Study Officials

  • Carolyn L. Westhoff, MD, MSc

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
NIH

Study Record Dates

First Submitted

September 10, 2003

First Posted

September 11, 2003

Study Start

February 1, 2003

Study Completion

March 1, 2005

Last Updated

April 10, 2007

Record last verified: 2007-04

Locations

US(3)