Trial Outcomes & Findings for Copper T380 IUD Versus Oral Levonorgestrel for Emergency Contraception vs. Plan B for Emergency Contraception (NCT NCT00669396)

Results Overview

Use of a method of contraception with a typical efficacy rate \>= to 92%. This includes combined hormonal contraception (combined oral contraceptive pills, the contraceptive patch and ring), sterilization, IUDs, Depo-provera, and contraceptive implants.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

57 participants

Primary outcome timeframe

6 months

Results posted on

2014-12-22

Participant Flow

Participant milestones

Participant milestones
Measure	Copper T380 IUD IUD	Levonorgestrel Oral levonorgestrel
Overall Study STARTED	23	34
Overall Study COMPLETED	13	22
Overall Study NOT COMPLETED	10	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Copper T380 IUD IUD	Levonorgestrel Oral levonorgestrel
Overall Study Lost to Follow-up	10	12

Baseline Characteristics

Copper T380 IUD Versus Oral Levonorgestrel for Emergency Contraception vs. Plan B for Emergency Contraception

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Copper T380 IUD n=23 Participants IUD	Levonorgestrel n=34 Participants Oral levonorgestrel	Total n=57 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=5 Participants	34 Participants n=7 Participants	57 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	24.7 years STANDARD_DEVIATION 6.7 • n=5 Participants	23.0 years STANDARD_DEVIATION 4.7 • n=7 Participants	23.7 years STANDARD_DEVIATION 5.6 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	34 Participants n=7 Participants	57 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	23 participants n=5 Participants	34 participants n=7 Participants	57 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Use of a method of contraception with a typical efficacy rate \>= to 92%. This includes combined hormonal contraception (combined oral contraceptive pills, the contraceptive patch and ring), sterilization, IUDs, Depo-provera, and contraceptive implants.

Outcome measures

Outcome measures
Measure	Copper T380 IUD n=13 Participants IUD	Levonorgestrel n=22 Participants Oral levonorgestrel
Use of an Effective Method of Contraception at 6 Months After Requesting Emergency Contraception	9 participants	13 participants

SECONDARY outcome

Timeframe: 6 months

positive urine pregnancy test at anytime within 6 months of presenting for emergency contraception.

Outcome measures

Outcome measures
Measure	Copper T380 IUD n=13 Participants IUD	Levonorgestrel n=22 Participants Oral levonorgestrel
Pregnancy	0 participants	2 participants

SECONDARY outcome

Timeframe: 6 months

diagnosis and treatment for pelvic inflammatory disease

Outcome measures

Outcome measures
Measure	Copper T380 IUD n=13 Participants IUD	Levonorgestrel n=22 Participants Oral levonorgestrel
Infection	0 participants	0 participants

SECONDARY outcome

Timeframe: 6 months

patient reports IUD expulsion, removal, or perforation OR one of these events was documented at the clinic where patient received care.

Outcome measures

Outcome measures
Measure	Copper T380 IUD n=13 Participants IUD	Levonorgestrel n=22 Participants Oral levonorgestrel
IUD Expulsion, Removal, or Perforation	5 participants	0 participants

Adverse Events

Copper T380 IUD

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Levonorgestrel

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

David Turok, MD

University of Utah

Phone: 801-581-7647

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place