Long-Acting Reversible Contraception

NCT ID: NCT01299116

Last Updated: 2018-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 916 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2016-12-31

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.

Conditions

Contraception

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Preference SARC

Participants received one of a variety of oral contraceptives or DMPA

Group Type: OTHER

DMPA

Intervention Type: DRUG

Injectable contraceptive, containing 150 mg depot medroxyprogesterone acetate (DMPA) and marketed in the US as Depo-Provera® or containing 104 mg DMPA and marketed as Depo-SubQ Provera 104®.

oral contraceptives

Intervention Type: DRUG

Oral contraceptives (any variety of formulations are permitted)

Randomized LARC

Participants receive one of the following interventions:

Implanon® or Nexplanon®; ParaGard®; Mirena®

Group Type: EXPERIMENTAL

Implanon®

Intervention Type: DRUG

Subdermal contraceptive implant, marketed in the US as Implanon® or Nexplanon® (containing 68 mg of etonogestrel)

ParaGard®

Intervention Type: DRUG

Intrauterine device marketed in the US as ParaGard® (a T-shaped plastic device containing 380mm2 of copper surface)

Mirena®

Intervention Type: DRUG

Intrauterine system, marketed in the US as Mirena® (containing 52 mg of levonorgestrel)

Randomized SARC

Participants received one of a variety of oral contraceptives or DMPA

Group Type: ACTIVE_COMPARATOR

DMPA

Intervention Type: DRUG

Injectable contraceptive, containing 150 mg depot medroxyprogesterone acetate (DMPA) and marketed in the US as Depo-Provera® or containing 104 mg DMPA and marketed as Depo-SubQ Provera 104®.

oral contraceptives

Intervention Type: DRUG

Oral contraceptives (any variety of formulations are permitted)

Interventions

DMPA

Injectable contraceptive, containing 150 mg depot medroxyprogesterone acetate (DMPA) and marketed in the US as Depo-Provera® or containing 104 mg DMPA and marketed as Depo-SubQ Provera 104®.

Intervention Type: DRUG

oral contraceptives

Oral contraceptives (any variety of formulations are permitted)

Intervention Type: DRUG

Implanon®

Subdermal contraceptive implant, marketed in the US as Implanon® or Nexplanon® (containing 68 mg of etonogestrel)

Intervention Type: DRUG

ParaGard®

Intrauterine device marketed in the US as ParaGard® (a T-shaped plastic device containing 380mm2 of copper surface)

Intervention Type: DRUG

Mirena®

Intrauterine system, marketed in the US as Mirena® (containing 52 mg of levonorgestrel)

Intervention Type: DRUG

Other Intervention Names

Nexplanon®

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 29 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

FHI 360

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Hubacher, PhD

Role: PRINCIPAL_INVESTIGATOR

FHI 360

Locations

Planned Parenthood Central North Carolina

Chapel Hill, North Carolina, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 27662799 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25500324 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29920171 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29470950 (View on PubMed)

Other Identifiers

10250

Identifier Type: -

Identifier Source: org_study_id