Safety and Acceptability of Vaginal Rings That Protect Women From Unintended Pregnancy

NCT01796613 | Completed Phase 2 DMC

• 1 other identifier: ITMC0313
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The study is a multidisciplinary research project and has two main aims:

1. 1.To determine the safety of a contraceptive vaginal ring (CVR) in women, with an emphasis on its effect on the vaginal microenvironment after different durations of use: the vaginal microbiome, biofilm formation on epithelial cells and rings, inflammation and immune activation in the vagina
2. 2.To investigate the feasibility, acceptability and adherence to vaginal ring use in Rwandan women, including attitudes towards a future multi-purpose vaginal ring for prevention of both pregnancy and sexually transmitted infections (STI).

Conditions

Contraception

Outcome Measures

Primary Outcomes (1)

• vaginal bacterial counts

  Changes from baseline (pre-ring use) in vaginal bacterial counts and in the absence/presence of bacterial vaginosis-related bacteria as measured with quantitative real time polymerase chain reaction (PCR).

  5 months

Secondary Outcomes (4)

• Incidence of adverse and serious adverse experiences

  5 months

• Changes in phenotype of bacterial vaginosis-related bacteria

  5 months

• Presence or absence of a biofilm on the contraceptive vaginal rings (CVRs)

  5 months

• Changes in inflammatory cytokines concentrations in Cervicovaginal lavage (CVLs)

  5 months

Study Arms (2)

Vaginal Ring - intermittent regimen

ACTIVE COMPARATOR

3 weeks ring use followed by one week of no ring use to allow menstruation

Device: Vaginal Ring - intermittent regimen

Vaginal Ring - continuous regimen

ACTIVE COMPARATOR

3 weeks of ring use with no off period. The next ring is immediately inserted after the previous one

Device: Vaginal Ring - continuous regimen

Interventions

Vaginal Ring - intermittent regimen DEVICE

NuvaRing® used intermittently. Nuvaring is a contraceptive vaginal ring, manufactured by N.V. Organon (a subsidiary of Merck \& Co., Inc.,), Oss, the Netherlands. It contains 11.7 mg etonogestrel and 2.7 mg ethinylestradiol. It releases etonogestrel and ethinylestradiol at an average amount of 0.120 mg and 0.015 mg, respectively per 24 hours, over a period of 3 weeks. It is approved since 2001 by most countries within the European Union, and in the United Stated by the FDA.

Also known as: NuvaRing®: etonogestrel/ethinylestradiol

Vaginal Ring - intermittent regimen

Vaginal Ring - continuous regimen DEVICE

NuvaRing® used continuously. Nuvaring is a contraceptive vaginal ring, manufactured by N.V. Organon (a subsidiary of Merck \& Co., Inc.,), Oss, the Netherlands. It contains 11.7 mg etonogestrel and 2.7 mg ethinylestradiol. It releases etonogestrel and ethinylestradiol at an average amount of 0.120 mg and 0.015 mg, respectively per 24 hours, over a period of 3 weeks. It is approved since 2001 by most countries within the European Union, and in the United Stated by the FDA.

Also known as: NuvaRing®: etonogestrel/ethinylestradiol

Vaginal Ring - continuous regimen

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Able and willing to give informed consent/assent, according to national guidelines
• Female who self-reports to be sexually active (meaning at least one penetrative vaginal coital act per month for the last 3 months prior to screening)
• Between 18 to 35 years old, inclusive
• Currently in good physical and mental health
• Interested in initiating hormonal contraception
• Able and willing to participate in the study as required by the protocol, this includes willing to undergo HIV testing and use a NuvaRing®
• HIV negative at screening as confirmed by rapid HIV testing

You may not qualify if:

• Currently using a modern contraceptive method other than barrier methods
• Use of a hormonal contraceptive method in the three months prior to the screening visit
• Currently using antimicrobial medication
• Pregnant on urine pregnancy test
• History of cardiovascular disease
• History of hysterectomy or genital tract surgery (including cervical polypectomy, dilatation and curettage, hysteroscopy, or laparoscopy) in the three months prior to the screening visit
• History of complications with hormonal contraception or with contra indications for the use of hormonal contraceptives such as:
• History or known predisposition for venous thrombosis
• History of migraine with focal neurological symptoms
• Diabetes mellitus with vascular involvement
• History of pancreatitis or severe hepatic disease
• Known or suspected hypersensitivity to any of the excipients of NuvaRing®
• History of significant urogenital or uterine prolapse, undiagnosed vaginal bleeding, incontinence or urge incontinence, diagnosed chronic and/or recurrent vulvovaginal candidiasis, urethral obstruction
• Participating in other clinical studies involving investigational products
• Currently breastfeeding

Sponsors & Collaborators

• Institute of Tropical Medicine, Belgium: lead
• Rinda Ubuzima: collaborator
• University of Liverpool: collaborator

Study Sites (1)

Rinda Ubuzima

Kigali, Rwanda

Location

Related Publications (2)

• Hardy L, Jespers V, Abdellati S, De Baetselier I, Mwambarangwe L, Musengamana V, van de Wijgert J, Vaneechoutte M, Crucitti T. A fruitful alliance: the synergy between Atopobium vaginae and Gardnerella vaginalis in bacterial vaginosis-associated biofilm. Sex Transm Infect. 2016 Nov;92(7):487-491. doi: 10.1136/sextrans-2015-052475. Epub 2016 Mar 10.

  PMID: 26965870 DERIVED

• Schurmans C, De Baetselier I, Kestelyn E, Jespers V, Delvaux T, Agaba SK, van Loen H, Menten J, van de Wijgert J, Crucitti T; RING PLUS study group. The ring plus project: safety and acceptability of vaginal rings that protect women from unintended pregnancy. BMC Public Health. 2015 Apr 10;15:348. doi: 10.1186/s12889-015-1680-y.

  PMID: 25880636 DERIVED

Study Officials

• Tania Crucitti, PhD

  Institute of Tropical Medicine, Belgium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2013
• First Posted: February 22, 2013
• Study Start: June 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: March 11, 2015

Record last verified: 2015-03

Locations

RW (1)