Quick Start Initiation of the Contraceptive Vaginal Ring in Adolescents

This study has been terminated.
(difficulty in subject recruitment)
Sponsor:
Collaborators:
American College of Obstetricians and Gynecologists
Bayer
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00369967
First received: August 29, 2006
Last updated: December 19, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Adolescents Seeking Contraception
Drug: NuvaRing

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: "Quick Start" Initiation of the Contraceptive Vaginal Ring in Adolescents: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Continuation with the contraceptive method [ Time Frame: 3,6, and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bleeding profile [ Time Frame: 3,6,and 12 mo ] [ Designated as safety issue: No ]
  • pregnancy [ Time Frame: 3,6, and 12 mo ] [ Designated as safety issue: No ]
  • product satisfaction [ Time Frame: 3,6,and 12 mo ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: February 2007
Study Completion Date: July 2010
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Quick start
Start method day of enrollment
Drug: NuvaRing
Initiation of NuvaRing for contraception
Active Comparator: Traditional start Drug: NuvaRing
Initiation of NuvaRing for contraception

Detailed Description:

Pregnancy prevention is an important aspect of adolescent healthcare. Adherence to a chosen contraception method is essential to its success. Adolescents are notoriously poor at complying with oral contraceptives (OCs), with continuation rates at one year as low as 12% (1). In those patients who continue their contraceptive method, our best data estimates that the average OC user misses three pills per cycle (2). Given the already highly fluctuant serum hormone levels in OC users (3), this leaves poorly compliant users at greater risk for unintended pregnancy.

The contraceptive vaginal ring is a reliable method of contraception and may be particularly useful in the adolescent population because of its simple monthly dosing schedule (4). It is a combined hormonal contraceptive containing etonogestrel (a progesterone) and ethinyl estradiol (an estrogen), which are released continuously at low levels. The vaginal ring has been shown to have comparable efficacy and tolerability to OCs (5), but does not require daily dosing due to its novel drug delivery system. Studies have shown high rates of acceptability and satisfaction with vaginal ring usage in adult and adolescent women and a high rate of continuation using a traditional start method (6).

The "quick start" method of initiating use of OCs has been found to improve continuation rates and overall method satisfaction compared to traditional start in large studies of adult women (7) and also in small studies of adolescents (8) without significantly affecting incidence of breakthrough bleeding or patient satisfaction (9). "Quick start" contraceptive vaginal ring has been studied in women aged 18-40 years and found to have a more favorable bleeding profile than "quick start" Ortho-Tricyclen Lo (10). This decreased incidence of altered bleeding may be a more favorable benefit of "quick start" contraceptive vaginal ring in the adolescent population as well.

One of the biggest obstacles to use of the contraceptive vaginal ring in clinical practice is having the patient overcome the idea of vaginally inserting the ring, especially in the adolescent population (11). It seems logical that initiating the vaginal ring in the office via the "quick start" method may improve patient acceptance and comfort with the method, thus improving continuation rates in these patients compared to traditional initiation.

We propose to perform a randomized controlled trial comparing "quick start" to traditional start NuvaRing in adolescents. Subjects meeting inclusion criteria will be randomized to either start the method in the office immediately or start the method within 5 days of her next menstrual period. Subjects will follow up at 3, 6, and 12 months, at which time we will assess continuation, bleeding patterns, pregnancy, and patient satisfaction.

  Eligibility

Ages Eligible for Study:   15 Years to 21 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: 1) female aged 15 through 21 presenting for contraception; 2) willing to use the NuvaRing as their contraceptive method; 3) English-speaking; 4) up to date on routine health maintenance screening (pap smear within 3 years of initiation of sexual intercourse and Gonorrhea/ Chlamydia testing yearly or with each new partner); and 5) able to read and understand the consent form.

Exclusion Criteria: 1) are pregnant; 2) have a contraindication to hormonal contraception; 3) are unwilling to use NuvaRing as their contraceptive method; 4) are currently using any hormonal contraceptive or have used one within past 2 months; 5) have used emergency contraception in the past 7 days; 6) have had unprotected intercourse in the past 10 days; 7) have untreated Gonorrhea or Chlamydia; or 8) are unable to give informed consent because of psychiatric or cognitive problems.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00369967

Locations
United States, Virginia
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
American College of Obstetricians and Gynecologists
Bayer
Investigators
Principal Investigator: Nicole W Karjane, MD Virginia Commonwealth University
  More Information

Publications:

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00369967     History of Changes
Other Study ID Numbers: 5120008FN
Study First Received: August 29, 2006
Last Updated: December 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:
Contraception
Adolescents
Contraceptive vaginal ring
Quick start

Additional relevant MeSH terms:
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on September 30, 2014