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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®

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
SARC - Preference

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)

LARC - Randomized

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)

SARC - Randomized

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®.


Participant Flow:   Overall Study
    SARC - Preference   LARC - Randomized   SARC - Randomized
STARTED   522   177   195 
COMPLETED   457   168   184 
NOT COMPLETED   65   9   11 
Lost to Follow-up                65                9                11 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Preference SARC

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)

Randomized LARC

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)

Randomized SARC

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 Total of all reporting groups

Baseline Measures
   Preference SARC   Randomized LARC   Randomized SARC   Total 
Overall Participants Analyzed 
[Units: Participants]
 522   177   195   894 
Age 
[Units: Years]
Mean (Inter-Quartile Range)
 23 
 (21 to 26) 
 23 
 (21 to 26) 
 23 
 (21 to 26) 
 23 
 (21 to 26) 
Sex: Female, Male 
[Units: Participants]
Count of 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] 
[Units: Participants]
Count of Participants
       
Hispanic   68   14   30   112 
Non-Hispanic, white   269   111   105   485 
Non-Hispanic, black   124   34   44   202 
All other single and multiple race   58   18   16   92 
[1] Three participants did not provide race/ethnicity information


  Outcome Measures

1.  Primary:   Contraceptive Method Discontinuation   [ Time Frame: 24 months ]

2.  Secondary:   Unintended Pregnancy   [ Time Frame: 24 months ]

3.  Secondary:   Participant Attitudes to LARC vs SARC   [ Time Frame: 24 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. David Hubacher
Organization: FHI 360
phone: 919 544 7040 ext 11223
e-mail: dhubacher@fhi360.org


Publications:

Responsible Party: FHI 360
ClinicalTrials.gov Identifier: NCT01299116     History of Changes
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