Quick Start Initiation of the Contraceptive Vaginal Ring in Adolescents

• Sponsor: Virginia Commonwealth University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00369967
• Collaborator: American College of Obstetricians and Gynecologists (Other), Bayer (Industry)
• Enrollment: 48
• Location: 1
• Arms: 2
• Duration (Months): 40.9
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Contraception Desired	Drug: NuvaRing	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Prevention
• Official Title: "Quick Start" Initiation of the Contraceptive Vaginal Ring in Adolescents: A Randomized Controlled Trial
• Study Start Date: Feb 1, 2007
• Actual Primary Completion Date: Jul 1, 2009
• Actual Study Completion Date: Jul 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Quick start Start contraceptive method (NuvaRing) day of enrollment	Drug: NuvaRing; Initiation of NuvaRing for contraception; Other Names: contraceptive vaginal ring
Active Comparator: Traditional start Start contraceptive method (NuvaRing) after next menses (per package insert)	Drug: NuvaRing; Initiation of NuvaRing for contraception; Other Names: contraceptive vaginal ring

Outcome Measures

Primary Outcome Measures

1. Continuation With the Contraceptive Method [3 months]

   Participants reporting continuation with contraceptive method at 3 months

2. Method Continuation at 6 Months [6 months]

   Participants reporting continuation of method at 6 months

3. Method Continuation at 12 Months [12 months]

   Participants reporting continuation with method at 12 months

Secondary Outcome Measures

1. Pregnancy [3,6, and 12 mo]

   Number of pregnancies reported

2. Bleeding Profile [3, 6, and 12 months]

3. Patient Satisfaction [3, 6, and 12 months]

   Rating of patient satisfaction with method

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 21 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• Novák 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.
• 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.
• 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.
• Rosenberg M, Waugh MS. Causes and consequences of oral contraceptive noncompliance. Am J Obstet Gynecol. 1999 Feb;180(2 Pt 2):276-9.
• 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.
• 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.
• 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.
• 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.
• 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.

• Responsible Party: Virginia Commonwealth University
• ClinicalTrials.gov Identifier: NCT00369967
• Other Study ID Numbers: 5120008FN
• First Posted: Aug 30, 2006
• Last Update Posted: Jul 22, 2016
• Last Verified: Jun 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Virginia Commonwealth University: Contraception; Adolescents; Contraceptive vaginal ring; Quick start
• Additional relevant MeSH terms: Contraceptive Agents; NuvaRing

Study Results

Participant Flow

Arm/Group Title	Traditional Start	Quick Start
Arm/Group Description	NuvaRing: Initiation of NuvaRing for contraception per package insert	NuvaRing: Initiation of NuvaRing for contraception on day of enrollment
Period Title: Overall Study
STARTED	31	17
COMPLETED	8	5
NOT COMPLETED	23	12

Baseline Characteristics

Arm/Group Title	Traditional Start	Quick Start	Total
Arm/Group Description	NuvaRing: Initiation of NuvaRing for contraception per package insert	NuvaRing: Initiation of NuvaRing for contraception on day of enrollment	Total of all reporting groups
Overall Participants	31	17	48
Age (Count of Participants)
<=18 years	5 16.1%	6 35.3%	11 22.9%
Between 18 and 65 years	26 83.9%	11 64.7%	37 77.1%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	19 (1.7)	18 (2.1)	18 (1.9)
Sex: Female, Male (Count of Participants)
Female	31 100%	17 100%	48 100%
Male	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	18 58.1%	11 64.7%	29 60.4%
White	11 35.5%	5 29.4%	16 33.3%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	2 6.5%	1 5.9%	3 6.3%
Region of Enrollment (participants) [Number]
United States	31 100%	17 100%	48 100%

Outcome Measures

1. Primary Outcome

Title	Continuation With the Contraceptive Method
Description	Participants reporting continuation with contraceptive method at 3 months
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

Number using method at 3 months

Arm/Group Title	Quick Start	Traditional Start
Arm/Group Description	Start method day of enrollment NuvaRing: Initiation of NuvaRing for contraception	NuvaRing: Initiation of NuvaRing for contraception
Measure Participants	17	31
Number [participants]	5 16.1%	11 64.7%

2. Primary Outcome

Title	Method Continuation at 6 Months
Description	Participants reporting continuation of method at 6 months
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Participants enrolled

Arm/Group Title	Traditional Start	Quick Start
Arm/Group Description	NuvaRing: Initiation of NuvaRing for contraception per package insert	NuvaRing: Initiation of NuvaRing for contraception on day of enrollment
Measure Participants	31	17
Number [participants]	7 22.6%	2 11.8%

3. Primary Outcome

Title	Method Continuation at 12 Months
Description	Participants reporting continuation with method at 12 months
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Participants enrolled

Arm/Group Title	Quick Start	Traditional Start
Arm/Group Description	NuvaRing: Initiation of NuvaRing for contraception on day of enrollment	NuvaRing: Initiation of NuvaRing for contraception per package insert
Measure Participants	17	31
Number [participants]	0 0%	2 11.8%

4. Secondary Outcome

Title	Pregnancy
Description	Number of pregnancies reported
Time Frame	3,6, and 12 mo

Outcome Measure Data

Analysis Population Description

There were no reported pregnancies during the study period

Arm/Group Title	Quick Start	Traditional Start
Arm/Group Description	NuvaRing: Initiation of NuvaRing for contraception on day of enrollment	NuvaRing: Initiation of NuvaRing for contraception per package insert
Measure Participants	17	31
Number [participants]	0 0%	0 0%

5. Secondary Outcome

Title	Bleeding Profile
Time Frame	3, 6, and 12 months

Outcome Measure Data

Analysis Population Description

None of the participants returned their menstrual calendars to assess this outcome

Arm/Group Title	Quick Start	Traditional Start
Arm/Group Description	NuvaRing: Initiation of NuvaRing for contraception on day of enrollment	NuvaRing: Initiation of NuvaRing for contraception per package insert
Measure Participants	0	0

6. Secondary Outcome

Title	Patient Satisfaction
Description	Rating of patient satisfaction with method
Time Frame	3, 6, and 12 months

Outcome Measure Data

Analysis Population Description

None of the participants returned their satisfaction survey

Arm/Group Title	Quick Start	Traditional Start
Arm/Group Description	NuvaRing: Initiation of NuvaRing for contraception on day of enrollment	NuvaRing: Initiation of NuvaRing for contraception per package insert
Measure Participants	0	0

Adverse Events

Arm/Group Title	Traditional Start		Quick Start
Arm/Group Description	NuvaRing: Initiation of NuvaRing for contraception per package insert		NuvaRing: Initiation of NuvaRing for contraception on day of enrollment
All Cause Mortality
	Traditional Start		Quick Start
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Traditional Start		Quick Start
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/31 (0%)		0/17 (0%)
Other (Not Including Serious) Adverse Events
	Traditional Start		Quick Start
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/31 (0%)		0/17 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.