Clinical trial NCT01299116: Long-Acting Reversible Contraception
Official title: Long-Acting Reversible Contraception: New Research to Reduce Unintended Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Contraception
Keywords: AE-adverse event
FDA-(U.S.) Food and Drug Administration
GCP-Good Clinical Practice guidelines
ICH-International Committee on Harmonisation
IRB-Institutional Review Board
IU-International units
mg-milligram(s)
mm3-cubic millimeter(s)
LARC-Long-Acting reversible contraception
PPCNC-Planned Parenthood of North Carolina
SAE-serious adverse event
SARC-Short-Acting reversible contraception
µg-microgram
ULN-upper limit of the normal range
SubQ-subcutaneous
Lead sponsor: FHI 360
Sponsor class: OTHER
First posted: 2011-02-18
Enrollment: 916
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Partially randomized patient preference trial
Primary purpose: PREVENTION

Brief summary: In the proposed study, women aged 18-29 seeking oral or injectable contraception will be offered an opportunity to try LARC instead; the FDA-approved options include two types of intrauterine products and one type of subdermal contraceptive implant. Over a 24 month period, the experiences of LARC users will be compared to the experiences of those opting for their initial short-acting method.

Detailed description: In this partially randomized patient preference study, women aged 18-29 seeking oral or injectable contraception will be offered an opportunity to try LARC instead; the FDA-approved options include two types of intrauterine products and one type of subdermal contraceptive implant. Over a 24-month period, the experiences of LARC users will be compared to the experiences of those opting for their initial short-acting method. It is expected that 38% of the participants using short-acting methods will stop using them during the first year and be at risk of unintended pregnancy. In contrast, less than 20% of LARC users will want to have their contraceptive removed. Continuation rates will be measured and pregnancies will be tallied in the two groups to document any differences that emerge.

Eligibility criteria: Inclusion Criteria:

* 18 to 29 years of age;
* sexually active;
* seeking oral or injectable contraception;
* working cell phone;
* working email account;
* willingness to be contacted by the clinic staff or study coordinators; and,
* willingness to complete questionnaires.

Exclusion Criteria:

* currently pregnant;
* previous use of a long-acting reversible contraceptive (LARC) method; and,
* medical contraindications for oral contraceptives and injectables.

Primary outcomes:
measure: Contraceptive Method Discontinuation
timeFrame: 24 months
Secondary outcomes:
measure: Unintended Pregnancy
timeFrame: 24 months
measure: Participant Attitudes to LARC vs SARC
timeFrame: 24 months
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Planned Parenthood Central North Carolina
state: North Carolina
Study officials:
affiliation: FHI 360
name: David Hubacher, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hubacher D, Spector H, Monteith C, Chen PL, Hart C. Long-acting reversible contraceptive acceptability and unintended pregnancy among women presenting for short-acting methods: a randomized patient preference trial. Am J Obstet Gynecol. 2017 Feb;216(2):101-109. doi: 10.1016/j.ajog.2016.08.033. Epub 2016 Sep 20.
citation: Hubacher D, Spector H, Monteith C, Chen PL, Hart C. Rationale and enrollment results for a partially randomized patient preference trial to compare continuation rates of short-acting and long-acting reversible contraception. Contraception. 2015 Mar;91(3):185-92. doi: 10.1016/j.contraception.2014.11.006. Epub 2014 Nov 15.
citation: Burke HM, Packer CA, Spector HL, Hubacher D. Opportunity, satisfaction, and regret: Trying long-acting reversible contraception in a unique scientific circumstance. Women Health. 2019 Mar;59(3):266-280. doi: 10.1080/03630242.2018.1478363. Epub 2018 Aug 1.
citation: Hubacher D, Spector H, Monteith C, Chen PL. Not seeking yet trying long-acting reversible contraception: a 24-month randomized trial on continuation, unintended pregnancy and satisfaction. Contraception. 2018 Jun;97(6):524-532. doi: 10.1016/j.contraception.2018.02.001. Epub 2018 Feb 19.