Quick Start Initiation of the Contraceptive Vaginal Ring in Adolescents

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.

Timeline

Start

2007-02

Primary completion

2009-07

Completion

2010-07

Outcome

Outcome not reported

Stopped (Enrollment): “difficulty in subject recruitment”

Publications

• Background 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Drugs

Indications

No indication recorded.