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Long-Acting Reversible Contraception (LARC)

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ClinicalTrials.gov Identifier: NCT01299116
Recruitment Status : Completed
First Posted : February 18, 2011
Results First Posted : January 26, 2018
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
FHI 360

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Contraception
Interventions Drug: DMPA
Drug: oral contraceptives
Drug: Implanon®
Drug: ParaGard®
Drug: Mirena®
Enrollment 916
Recruitment Details  
Pre-assignment Details This is a partially randomized patient preference trial. Twenty two participants did not contribute data for analysis because they did not start a contraceptive in one of the three groups. For more information see: Hubacher D et al., 2017. The total number going forward for analysis is 894.
Arm/Group Title SARC - Preference LARC - Randomized SARC - Randomized
Hide Arm/Group Description

Participants received one of a variety of oral contraceptives or DMPA

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®.

oral contraceptives: Oral contraceptives (any variety of formulations are permitted)

Participants receive one of the following interventions:

Implanon® or Nexplanon®; ParaGard®; Mirena®

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

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

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

Participants received one of a variety of oral contraceptives or DMPA

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®.

Period Title: Overall Study
Started 522 177 195
Completed 457 168 184
Not Completed 65 9 11
Reason Not Completed
Lost to Follow-up             65             9             11
Arm/Group Title Preference SARC Randomized LARC Randomized SARC Total
Hide Arm/Group Description

Participants received one of a variety of oral contraceptives or DMPA

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®.

oral contraceptives: Oral contraceptives (any variety of formulations are permitted)

Participants receive one of the following interventions:

Implanon® or Nexplanon®; ParaGard®; Mirena®

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

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

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

Participants received one of a variety of oral contraceptives or DMPA

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®.

oral contraceptives: Oral contraceptives (any variety of formulations are permitted)

Total of all reporting groups
Overall Number of Baseline Participants 522 177 195 894
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 522 participants 177 participants 195 participants 894 participants
23
(21 to 26)
23
(21 to 26)
23
(21 to 26)
23
(21 to 26)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 522 participants 177 participants 195 participants 894 participants
Female
522
 100.0%
177
 100.0%
195
 100.0%
894
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 522 participants 177 participants 195 participants 894 participants
Hispanic
68
  13.0%
14
   7.9%
30
  15.4%
112
  12.5%
Non-Hispanic, white
269
  51.5%
111
  62.7%
105
  53.8%
485
  54.3%
Non-Hispanic, black
124
  23.8%
34
  19.2%
44
  22.6%
202
  22.6%
All other single and multiple race
58
  11.1%
18
  10.2%
16
   8.2%
92
  10.3%
[1]
Measure Description: Three participants did not provide race/ethnicity information
1.Primary Outcome
Title Contraceptive Method Discontinuation
Hide Description [Not Specified]
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SARC - Preference LARC - Randomized SARC - Randomized
Hide Arm/Group Description:

Participants received one of a variety of oral contraceptives or DMPA

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®.

oral contraceptives: Oral contraceptives (any variety of formulations are permitted)

Participants receive one of the following interventions:

Implanon® or Nexplanon®; ParaGard®; Mirena®

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

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

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

Participants received one of a variety of oral contraceptives or DMPA

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®.

Overall Number of Participants Analyzed 522 177 195
Measure Type: Count of Participants
Unit of Measure: Participants
300
  57.5%
62
  35.0%
142
  72.8%
2.Secondary Outcome
Title Unintended Pregnancy
Hide Description Intent-to-treat principles applied.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SARC - Preference LARC - Randomized SARC - Randomized
Hide Arm/Group Description:

Participants received one of a variety of oral contraceptives or DMPA

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®.

oral contraceptives: Oral contraceptives (any variety of formulations are permitted)

Participants receive one of the following interventions:

Implanon® or Nexplanon®; ParaGard®; Mirena®

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

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

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

Participants received one of a variety of oral contraceptives or DMPA

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®.

Overall Number of Participants Analyzed 466 168 187
Measure Type: Count of Participants
Unit of Measure: Participants
47
  10.1%
6
   3.6%
13
   7.0%
3.Secondary Outcome
Title Participant Attitudes to LARC vs SARC
Hide Description Level of happiness with initial method (% distribution)
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Preference SARC Randomized LARC Randomized SARC
Hide Arm/Group Description:

Participants received one of a variety of oral contraceptives or DMPA

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®.

oral contraceptives: Oral contraceptives (any variety of formulations are permitted)

Participants receive one of the following interventions:

Implanon® or Nexplanon®; ParaGard®; Mirena®

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

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

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

Participants received one of a variety of oral contraceptives or DMPA

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®.

oral contraceptives: Oral contraceptives (any variety of formulations are permitted)

Overall Number of Participants Analyzed 522 177 195
Measure Type: Count of Participants
Unit of Measure: Participants
Happy
354
  67.8%
120
  67.8%
138
  70.8%
Neutral
52
  10.0%
15
   8.5%
24
  12.3%
Unhappy
50
   9.6%
33
  18.6%
22
  11.3%
Missing
66
  12.6%
9
   5.1%
11
   5.6%
Time Frame 24 months
Adverse Event Reporting Description Only serious adverse events were collected. AEs not captured.
 
Arm/Group Title SARC - Preference LARC - Randomized SARC - Randomized
Hide Arm/Group Description

Participants received one of a variety of oral contraceptives or DMPA

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®.

oral contraceptives: Oral contraceptives (any variety of formulations are permitted)

Participants receive one of the following interventions:

Implanon® or Nexplanon®; ParaGard®; Mirena®

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

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

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

Participants received one of a variety of oral contraceptives or DMPA

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®.

All-Cause Mortality
SARC - Preference LARC - Randomized SARC - Randomized
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/522 (0.00%)      0/177 (0.00%)      0/195 (0.00%)    
Hide Serious Adverse Events
SARC - Preference LARC - Randomized SARC - Randomized
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/522 (0.00%)      1/177 (0.56%)      0/195 (0.00%)    
Reproductive system and breast disorders       
endometritis *  0/522 (0.00%)  0 1/177 (0.56%)  1 0/195 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
SARC - Preference LARC - Randomized SARC - Randomized
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/0      0/0      0/0    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. David Hubacher
Organization: FHI 360
Phone: 919 544 7040 ext 11223
EMail: dhubacher@fhi360.org
Layout table for additonal information
Responsible Party: FHI 360
ClinicalTrials.gov Identifier: NCT01299116    
Other Study ID Numbers: 10250
First Submitted: February 16, 2011
First Posted: February 18, 2011
Results First Submitted: November 14, 2017
Results First Posted: January 26, 2018
Last Update Posted: February 28, 2018