Improving Adolescent Adherence to Hormonal Contraception

Contraception Clinical Trial

Official title:

Improving Adolescent Adherence to Hormonal Contraception

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00584038
• Other study ID #: 06-060
• Secondary ID: R40MC06634
• Status: Completed
• Phase: N/A
• First received: December 20, 2007
• Last updated: May 23, 2013
• Start date: January 2006
• Est. completion date: March 2012

Study information

• Verified date: May 2013
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1155
• Est. completion date: March 2012
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 24 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Contraception

Intervention

Behavioral:
• educational instruction and phone follow-up
Educational instruction and phone follow-up.
• educational instruction in clinic
Educational instruction in clinic.

Locations

Country	Name	City	State
United States	The University of Texas Medical Branch	Galveston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of contraceptive adherence		12 months	No
Primary	Measurement of dual method use		12 months	No
Primary	Measurement of pregnancy rates and sexually transmitted diseases (STDs)		12 months	No
Secondary	Measurement of contraceptive side effects		12 months	No
Secondary	Measurement of satisfaction with method		12 months	No
Secondary	Measurement of sexual activity		12 months	No