Quick Start Initiation of the Contraceptive Vaginal Ring in Adolescents

NCT00369967 | Terminated Results

• 1 other identifier: 5120008FN
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

We hypothesize that using "quick start" initiation of the contraceptive vaginal ring in adolescents seeking birth control will improve compliance compared to traditional start. We will conduct a randomized controlled trial comparing "quick start" to traditional start initiation of the contraceptive vaginal ring in adolescents seeking birth control. The primary study outcome is method continuation at 3, 6, and 12 months. Secondary outcomes include abnormal bleeding, product satisfaction, and adverse events.

Conditions

Contraception Desired

Keywords

Contraception; Adolescents; Contraceptive vaginal ring; Quick start

Outcome Measures

Primary Outcomes (3)

• Continuation With the Contraceptive Method

  Participants reporting continuation with contraceptive method at 3 months

  3 months

• Method Continuation at 6 Months

  Participants reporting continuation of method at 6 months

  6 months

• Method Continuation at 12 Months

  Participants reporting continuation with method at 12 months

  12 months

Secondary Outcomes (3)

• Pregnancy

  3,6, and 12 mo

• Bleeding Profile

  3, 6, and 12 months

• Patient Satisfaction

  3, 6, and 12 months

Study Arms (2)

Quick start

EXPERIMENTAL

Start contraceptive method (NuvaRing) day of enrollment

Drug: NuvaRing

Traditional start

ACTIVE COMPARATOR

Start contraceptive method (NuvaRing) after next menses (per package insert)

Drug: NuvaRing

Interventions

NuvaRing DRUG

Initiation of NuvaRing for contraception

Also known as: contraceptive vaginal ring

Quick start; Traditional start

Eligibility Criteria

• Age: 15 Years - 21 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• American College of Obstetricians and Gynecologists: collaborator
• Bayer: collaborator

Study Sites (1)

Virginia Commonwealth University Medical Center

Richmond, Virginia, 23298, United States

Location

Related Publications (10)

• Zibners A, Cromer BA, Hayes J. Comparison of continuation rates for hormonal contraception among adolescents. J Pediatr Adolesc Gynecol. 1999 May;12(2):90-4. doi: 10.1016/s1083-3188(00)86633-4.

  PMID: 10326194 BACKGROUND

• Rosenberg M, Waugh MS. Causes and consequences of oral contraceptive noncompliance. Am J Obstet Gynecol. 1999 Feb;180(2 Pt 2):276-9. doi: 10.1016/s0002-9378(99)70718-0.

  PMID: 9988830 BACKGROUND

• van den Heuvel MW, van Bragt AJ, Alnabawy AK, Kaptein MC. Comparison of ethinylestradiol pharmacokinetics in three hormonal contraceptive formulations: the vaginal ring, the transdermal patch and an oral contraceptive. Contraception. 2005 Sep;72(3):168-74. doi: 10.1016/j.contraception.2005.03.005.

  PMID: 16102549 BACKGROUND

• Rivera R, Cabral de Mello M, Johnson SL, Chandra-Mouli V. Contraception for adolescents: social, clinical and service-delivery considerations. Int J Gynaecol Obstet. 2001 Nov;75(2):149-63. doi: 10.1016/s0020-7292(01)00371-x.

  PMID: 11684110 BACKGROUND

• Novak A, de la Loge C, Abetz L, van der Meulen EA. The combined contraceptive vaginal ring, NuvaRing: an international study of user acceptability. Contraception. 2003 Mar;67(3):187-94. doi: 10.1016/s0010-7824(02)00514-0.

  PMID: 12618252 BACKGROUND

• Oddsson K, Leifels-Fischer B, de Melo NR, Wiel-Masson D, Benedetto C, Verhoeven CH, Dieben TO. Efficacy and safety of a contraceptive vaginal ring (NuvaRing) compared with a combined oral contraceptive: a 1-year randomized trial. Contraception. 2005 Mar;71(3):176-82. doi: 10.1016/j.contraception.2004.09.001.

  PMID: 15722066 BACKGROUND

• Westhoff C, Kerns J, Morroni C, Cushman LF, Tiezzi L, Murphy PA. Quick start: novel oral contraceptive initiation method. Contraception. 2002 Sep;66(3):141-5. doi: 10.1016/s0010-7824(02)00351-7.

  PMID: 12384200 BACKGROUND

• Lara-Torre E, Schroeder B. Adolescent compliance and side effects with Quick Start initiation of oral contraceptive pills. Contraception. 2002 Aug;66(2):81-5. doi: 10.1016/s0010-7824(02)00326-8.

  PMID: 12204779 BACKGROUND

• Westhoff C, Morroni C, Kerns J, Murphy PA. Bleeding patterns after immediate vs. conventional oral contraceptive initiation: a randomized, controlled trial. Fertil Steril. 2003 Feb;79(2):322-9. doi: 10.1016/s0015-0282(02)04680-0.

  PMID: 12568841 BACKGROUND

• Westhoff C, Osborne LM, Schafer JE, Morroni C. Bleeding patterns after immediate initiation of an oral compared with a vaginal hormonal contraceptive. Obstet Gynecol. 2005 Jul;106(1):89-96. doi: 10.1097/01.AOG.0000164483.13326.59.

  PMID: 15994622 BACKGROUND

MeSH Terms

Interventions

NuvaRing

Results Point of Contact

• Title: Nicole Karjane
• Organization: VCUHS

nkarjane@mcvh-vcu.edu

804-828-8614

Study Officials

• Nicole W Karjane, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2006
• First Posted: August 30, 2006
• Study Start: February 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2010
• Last Updated: July 22, 2016
• Results First Posted: July 22, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)