Trial Outcomes & Findings for Pericoital Oral Contraception With Levonorgestrel (NCT NCT00922233)

Last Updated: 2013-10-29

Results Overview

Participants were followed for 6.5 months.Pearl Index in the 18-35 year population was collected excluding months in which barrier methods, condoms, or emergency contraception were used unless the subject conceived

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

72 participants

Primary outcome timeframe

6.5 months

Results posted on

2013-10-29

Participant Flow

Participant milestones

Participant milestones
Measure	Levonorgestrel Only one study arm. All women were assigned to take 0.75 mg oral contraceptive pills (levonorgestrel) within 24 hours of engaging in sex.
Overall Study STARTED	72
Overall Study COMPLETED	68
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pericoital Oral Contraception With Levonorgestrel

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Levonorgestrel n=72 Participants 0.75 mg levonorgestrel oral contraceptive pills (levonorgestrel) : oral contraceptive pills
Age Continuous	32.4 years STANDARD_DEVIATION 6.9 • n=5 Participants
Sex: Female, Male Female	72 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment Africa	72 participants n=5 Participants

PRIMARY outcome

Timeframe: 6.5 months

Outcome measures

Outcome measures
Measure	Levonorgestrel n=68 Participants 0.75 mg levonorgestrel oral contraceptive pills
Efficacy: the Pearl Index (Number of Pregnancies Per 100 Woman-years) in the Primary Evaluable Population (18-35)	22.4 pregnancies per 100 woman years

PRIMARY outcome

Timeframe: 6.5 months

Population: A total of 58 women documented use of product on coital diaries and are included in the User Population for primary safety analysis. Numbers reported in the participant Flow module, represent the total enrolled and the maximum number available for evaluation. Not all the enrolled participants could be analyzed for every outcome measure.

Safety data includes data from each subject up to two weeks after her last use of the study tablets as well as all events deemed related to study product, regardless of date last tablet was taken

Outcome measures

Outcome measures
Measure	Levonorgestrel n=58 Participants 0.75 mg levonorgestrel oral contraceptive pills
Participant Report of Adverse Events.	45 adverse events

SECONDARY outcome

Timeframe: 6.5 months

Population: A total of 56 women reported on their bleeding patterns, of these, 43 found it acceptable. Numbers reported in the participant Flow module, represent the total enrolled and the maximum number available for evaluation. Not all the enrolled participants could be analyzed for every outcome measure.

Number of participants who reported bleeding patterns were acceptable and would therefore use Levonorgestrel

Outcome measures

Outcome measures
Measure	Levonorgestrel n=56 Participants 0.75 mg levonorgestrel oral contraceptive pills
Acceptability Based on Bleeding Patterns Reported	43 participants

Adverse Events

Levonorgestrel Arm

Serious events: 0 serious events

Other events: 28 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Levonorgestrel Arm n=72 participants at risk Only one study arm. All women were assigned to take 0.75 mg oral contraceptive pills (levonorgestrel) within 24 hours of engaging in sex.
Blood and lymphatic system disorders anemia	13.9% 10/72 • Number of events 11
Gastrointestinal disorders nausea	2.8% 2/72 • Number of events 2
Gastrointestinal disorders vomiting	1.4% 1/72 • Number of events 1
General disorders irritability	1.4% 1/72 • Number of events 1
Immune system disorders hypersensitivity	1.4% 1/72 • Number of events 1
Infections and infestations Cellulitis	1.4% 1/72 • Number of events 1
Infections and infestations chlamydial infection	1.4% 1/72 • Number of events 1
Infections and infestations ear infection	1.4% 1/72 • Number of events 1
Infections and infestations influenza	1.4% 1/72 • Number of events 1
Infections and infestations rhinitis	1.4% 1/72 • Number of events 1
Infections and infestations sinusitis	1.4% 1/72 • Number of events 1
Infections and infestations tonsilitis	1.4% 1/72 • Number of events 1
Infections and infestations upper respiratory tract infection	2.8% 2/72 • Number of events 2
Infections and infestations urinary tract infections	1.4% 1/72 • Number of events 1
Infections and infestations vaginal candidiasis	6.9% 5/72 • Number of events 5
Musculoskeletal and connective tissue disorders pain in extremity	1.4% 1/72 • Number of events 1
Nervous system disorders headache	4.2% 3/72 • Number of events 4
Renal and urinary disorders dysuria	1.4% 1/72 • Number of events 1
Reproductive system and breast disorders cervical dysplasia	1.4% 1/72 • Number of events 1
Reproductive system and breast disorders decereased libido	1.4% 1/72 • Number of events 1
Reproductive system and breast disorders vaginal discharge	4.2% 3/72 • Number of events 3
Respiratory, thoracic and mediastinal disorders cough	1.4% 1/72 • Number of events 1
Skin and subcutaneous tissue disorders dermititis allergic	1.4% 1/72 • Number of events 1
Skin and subcutaneous tissue disorders seborrhea	1.4% 1/72 • Number of events 1

Additional Information

Dr. Vera Halpern

FHI360

Phone: 9195447040

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place