PregnancyPhase 4NCT00068848
Quick Start Approach to Birth Control Pills
A Phase 4 study testing Quick start oral contraceptive initiation in people with Pregnancy and Contraception, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 24 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Contraception
- What is being tested?
- Quick start oral contraceptive initiation
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 2,000 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2003to Mar 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 24 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Emory University School of Medicine
Atlanta, Georgia, 30303
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75235
Mt. Sinai School of Medicine
New York, New York, 10128
About this study
Official title: RCT of a Novel Oral Contraceptive Initiation Method
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.
Read the detailed description
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.
- Conditions
- Pregnancy, Contraception
- Being tested
- Quick start oral contraceptive initiation
- Keywords
- Oral Contraceptives, Initiation, Continuation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quick start oral contraceptive initiationBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2003 (estimated)
- Study startFeb 2003
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 2,000 participants
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Investigators
- Carolyn L. Westhoff, MD, MSc, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00068848
- Sponsor's protocol ID
- HD42413
- Status last verified
- Apr 2007
- First submitted
- 10 Sep 2003
- Last updated
- 10 Apr 2007
- Results posted
- No
Publications
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.
PubMed 17540797
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RCT of a Novel Oral Contraceptive Initiation Method
- ClinicalTrials.gov ID
- NCT00068848
- Acronym / sponsor ID
- HD42413
- Conditions
- Pregnancy, Contraception
- Keywords
- Oral Contraceptives, Initiation, Continuation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,000 participants
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- Feb 2003
- Study completion
- Mar 2005
- First posted
- 11 Sep 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 24 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quick start oral contraceptive initiation | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2007.
- Derived from this study: PubMed 17540797Westhoff 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carolyn L. Westhoff, MD, MSc principal investigator
Columbia University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Quick start oral contraceptive initiation in people with Pregnancy and Contraception, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00068848, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2007; AzTrials last refreshed its copy on 31 Oct 2026.