Trial · NCT01299116

Long-Acting Reversible Contraception

NCT01299116, Phase 4, Completed, FHI 360; results first posted 2018-01-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Long-Acting Reversible Contraception. Trials, record NCT01299116. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01299116

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Long-Acting Reversible Contraception
NCT number: NCT01299116
Status: Completed
Phases: Phase 4
Enrollment: 916 participants, actual
Lead sponsor: FHI 360
Conditions: Contraception
Interventions: DMPA, oral contraceptives, Implanon®, ParaGard®, Mirena®
First posted: 2011-02-18
Last updated: 2018-02-28
Results first posted: 2018-01-26

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Contraceptive Method Discontinuation	24 months
Secondary	Unintended Pregnancy	24 months	Intent-to-treat principles applied.
Secondary	Participant Attitudes to LARC vs SARC	24 months	Level of happiness with initial method (% distribution)

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Contraceptive Method Discontinuation	24 months	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Unintended Pregnancy	24 months	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Participant Attitudes to LARC vs SARC	24 months	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group18

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Contraceptive Method Discontinuation	SARC - Preference		300	Participants
Contraceptive Method Discontinuation	LARC - Randomized		62	Participants
Contraceptive Method Discontinuation	SARC - Randomized		142	Participants
Unintended Pregnancy	SARC - Preference		47	Participants
Unintended Pregnancy	LARC - Randomized		6	Participants
Unintended Pregnancy	SARC - Randomized		13	Participants
Participant Attitudes to LARC vs SARC	Preference SARC	Happy	354	Participants
Participant Attitudes to LARC vs SARC	Randomized LARC	Happy	120	Participants
Participant Attitudes to LARC vs SARC	Randomized SARC	Happy	138	Participants
Participant Attitudes to LARC vs SARC	Preference SARC	Neutral	52	Participants

1 to 10 of 18Source ClinicalTrials.gov

See all 18 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	SARC - Preference	522
Overall Study	STARTED	LARC - Randomized	177
Overall Study	STARTED	SARC - Randomized	195
Overall Study	COMPLETED	SARC - Preference	457
Overall Study	COMPLETED	LARC - Randomized	168
Overall Study	COMPLETED	SARC - Randomized	184
Overall Study	NOT COMPLETED	SARC - Preference	65
Overall Study	NOT COMPLETED	LARC - Randomized	9
Overall Study	NOT COMPLETED	SARC - Randomized	11

Source ClinicalTrials.gov

Adverse events3

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
serious	endometritis	Reproductive system and breast disorders	SARC - Preference	0	522	0
serious	endometritis	Reproductive system and breast disorders	LARC - Randomized	1	177	1
serious	endometritis	Reproductive system and breast disorders	SARC - Randomized	0	195	0

Source ClinicalTrials.gov

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	SARC - Preference	0	522
Total, all-cause mortality	LARC - Randomized	0	177
Total, all-cause mortality	SARC - Randomized	0	195
Total, other adverse events	SARC - Preference	0	0
Total, other adverse events	LARC - Randomized	0	0
Total, other adverse events	SARC - Randomized	0	0
Total, serious adverse events	SARC - Preference	0	522
Total, serious adverse events	LARC - Randomized	1	177
Total, serious adverse events	SARC - Randomized	0	195

Source ClinicalTrials.gov

Papers4

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
25500324	BACKGROUND	PubMed
27662799	BACKGROUND	PubMed
29470950	DERIVED	PubMed
29920171	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01299116

GET https://conductscience.org/api/trials/v1/NCT01299116/registered

API reference For AI assistants