ContraceptionPhase 4LARCNCT01299116
Long-Acting Reversible Contraception
A Phase 4 study testing DMPA, oral contraceptives and Implanon® in people with Contraception, run by FHI 360 at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 29 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- DMPA, oral contraceptives and Implanon®
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 916 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Dec 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- currently pregnant;
- previous use of a long-acting reversible contraceptive (LARC) method; and,
- medical contraindications for oral contraceptives and injectables.
Trial locations and contacts
1 site in 1 country.
United States1 site
Planned Parenthood Central North Carolina
Chapel Hill, North Carolina, 27514
About this study
Official title: Long-Acting Reversible Contraception: New Research to Reduce Unintended Pregnancy
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.
Read the 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
- Being tested
- DMPA, oral contraceptives, Implanon®, ParaGard®, Mirena®
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DMPADrug
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 contraceptivesDrug
Oral contraceptives (any variety of formulations are permitted)
Implanon®Drug
Also called Nexplanon®
Subdermal contraceptive implant, marketed in the US as Implanon® or Nexplanon® (containing 68 mg of etonogestrel)
ParaGard®Drug
Intrauterine device marketed in the US as ParaGard® (a T-shaped plastic device containing 380mm2 of copper surface)
Mirena®Drug
Intrauterine system, marketed in the US as Mirena® (containing 52 mg of levonorgestrel)
| Study group | Role | What they receive |
|---|---|---|
| Preference SARC | Other | Participants received one of a variety of oral contraceptives or DMPA Receives: Drug: DMPA; Drug: oral contraceptives |
| Randomized LARC | Experimental | Participants receive one of the following interventions:
Implanon® or Nexplanon®; ParaGard®; Mirena® Receives: Drug: Implanon®; Drug: ParaGard®; Drug: Mirena® |
| Randomized SARC | Active comparator | Participants received one of a variety of oral contraceptives or DMPA Receives: Drug: DMPA; Drug: oral contraceptives |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contraceptive Method Discontinuation
Measured: 24 months
Secondary outcomes (2)
Unintended Pregnancy
Intent-to-treat principles applied.
Measured: 24 months
Participant Attitudes to LARC vs SARC
Level of happiness with initial method (% distribution)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2011 (estimated)
- Study startDec 2011
- Primary completionJun 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Partially randomized patient preference trial
- Masking
- None (open label)
- Enrolment
- 916 participants (actual)
Sponsor and investigators
- Lead sponsor
- FHI 360
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Hubacher, PhD, Principal investigator, FHI 360
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01299116
- Sponsor's protocol ID
- 10250
- Acronym
- LARC
- Status last verified
- Jan 2018
- First submitted
- 16 Feb 2011
- Last updated
- 28 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27662799Hubacher 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.
PubMed 25500324Burke 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.
PubMed 29920171Hubacher 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.
PubMed 29470950
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Acting Reversible Contraception: New Research to Reduce Unintended Pregnancy
- ClinicalTrials.gov ID
- NCT01299116
- Acronym / sponsor ID
- LARC / 10250
- 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)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 916 participants (actual)
- Lead sponsor
- FHI 360University, hospital or other
- Study start
- Dec 2011 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 18 Feb 2011 (estimated)
- Results
- Posted 26 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Partially randomized patient preference trial
| Arm | Type | Receives |
|---|---|---|
| Preference SARC | Other | Drug: DMPA, Drug: oral contraceptivesParticipants received one of a variety of oral contraceptives or DMPA |
| Randomized LARC | Experimental | Drug: Implanon®, Drug: ParaGard®, Drug: Mirena®Participants receive one of the following interventions: Implanon® or Nexplanon®; ParaGard®; Mirena® |
| Randomized SARC | Active comparator | Drug: DMPA, Drug: oral contraceptivesParticipants received one of a variety of oral contraceptives or DMPA |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 18 to 29 years of age;
- sexually active;
- seeking oral or injectable contraception;
- working cell phone;
- working email account;
Key exclusion criteria (3 listed)
- currently pregnant;
- previous use of a long-acting reversible contraceptive (LARC) method; and,
- medical contraindications for oral contraceptives and injectables.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DMPAInjectable 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®. | Drug | Preference SARC, Randomized SARC |
| oral contraceptivesOral contraceptives (any variety of formulations are permitted) | Drug | Preference SARC, Randomized SARC |
| Implanon®Also: Nexplanon®Subdermal contraceptive implant, marketed in the US as Implanon® or Nexplanon® (containing 68 mg of etonogestrel) | Drug | Randomized LARC |
| ParaGard®Intrauterine device marketed in the US as ParaGard® (a T-shaped plastic device containing 380mm2 of copper surface) | Drug | Randomized LARC |
| Mirena®Intrauterine system, marketed in the US as Mirena® (containing 52 mg of levonorgestrel) | Drug | Randomized LARC |
Primary outcome
Contraceptive Method Discontinuation
Time frame: 24 months
2 secondary outcomes
Unintended Pregnancy
Time frame: 24 months
Participant Attitudes to LARC vs SARC
Time frame: 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27662799Hubacher 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.
- Background: PubMed 25500324Hubacher 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.
- Derived from this study: PubMed 29920171Burke 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.
- Derived from this study: PubMed 29470950Hubacher 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Hubacher, PhD principal investigator
FHI 360
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing DMPA, oral contraceptives and Implanon® in people with Contraception, run by FHI 360 at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contraceptive Method Discontinuation (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01299116, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2018.