Long-Acting Reversible Contraception

NCT01299116 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 10250
• Study Type: interventional
• Target: 916
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Contraceptive Method Discontinuation

  24 months

Secondary Outcomes (2)

• Unintended Pregnancy

  24 months

• Participant Attitudes to LARC vs SARC

  24 months

Study Arms (3)

Preference SARC

OTHER

Participants received one of a variety of oral contraceptives or DMPA

Drug: DMPA; Drug: oral contraceptives

Randomized LARC

EXPERIMENTAL

Participants receive one of the following interventions: Implanon® or Nexplanon®; ParaGard®; Mirena®

Drug: Implanon®; Drug: ParaGard®; Drug: Mirena®

Randomized SARC

ACTIVE COMPARATOR

Participants received one of a variety of oral contraceptives or DMPA

Drug: DMPA; Drug: oral contraceptives

Interventions

DMPA 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®.

Preference SARC; Randomized SARC

oral contraceptives DRUG

Oral contraceptives (any variety of formulations are permitted)

Preference SARC; Randomized SARC

Implanon® DRUG

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

Also known as: Nexplanon®

Randomized LARC

ParaGard® DRUG

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

Randomized LARC

Mirena® DRUG

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

Randomized LARC

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• FHI 360: lead

Study Sites (1)

Planned Parenthood Central North Carolina

Chapel Hill, North Carolina, 27514, United States

Location

Related Publications (4)

• 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.

  PMID: 27662799 BACKGROUND

• 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.

  PMID: 25500324 BACKGROUND

• 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.

  PMID: 29920171 DERIVED

• 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.

  PMID: 29470950 DERIVED

MeSH Terms

Interventions

N,N-dimethyl-4-anisidine; Contraceptives, Oral; etonogestrel; Levonorgestrel

Intervention Hierarchy (Ancestors)

Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Norgestrel; Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Dr. David Hubacher
• Organization: FHI 360

dhubacher@fhi360.org

919 544 7040

Study Officials

• David Hubacher, PhD

  FHI 360

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Partially randomized patient preference trial

Study Record Dates

• First Submitted: February 16, 2011
• First Posted: February 18, 2011
• Study Start: December 1, 2011
• Primary Completion: June 1, 2016
• Study Completion: December 1, 2016
• Last Updated: February 28, 2018
• Results First Posted: January 26, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)