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Improving Adolescent Adherence to Hormonal Contraception

Improving Adolescent Adherence to Hormonal Contraception

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00584038
Enrollment
1155
Registered
2008-01-02
Start date
2006-01-31
Completion date
2012-03-31
Last updated
2013-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraception

Keywords

contraceptive compliance, educational intervention, oral contraception

Brief summary

The purpose of this study is to determine whether contraceptive compliance by young women can be improved through expanded counseling by a health educator at the initial clinic visit as compared with standard care.

Interventions

BEHAVIORALeducational instruction and phone follow-up

Educational instruction and phone follow-up.

BEHAVIORALeducational instruction in clinic

Educational instruction in clinic.

Sponsors

The University of Texas Medical Branch, Galveston
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
16 Years to 24 Years
Healthy volunteers
Yes

Inclusion criteria

* Sexually active females 16 to 24 years of age who present to a University of Texas Medical Branch (UTMB) clinic and request to initiate oral contraception for birth control.

Exclusion criteria

* Women who are currently pregnant or breastfeeding. * Women who wish to become pregnant within the next 12 months. * Women who have a medical contraindication to use of estrogen (e.g., thromboembolic disease, acute liver disease, breast cancer, genital cancer, or undiagnosed genital bleeding). * Women wishing to initiate use of a contraceptive method that is not oral, such as transdermal (the patch) or injectable (DMPA) methods, or the vaginal ring. * Current and previous users of oral contraceptives.

Design outcomes

Primary

MeasureTime frame
Measurement of pregnancy rates and sexually transmitted diseases (STDs)12 months
Measurement of contraceptive adherence12 months
Measurement of dual method use12 months

Secondary

MeasureTime frame
Measurement of contraceptive side effects12 months
Measurement of satisfaction with method12 months
Measurement of sexual activity12 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026