Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 20 of 404 for:    LEVONORGESTREL

Pericoital Oral Contraception With Levonorgestrel

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00922233
Recruitment Status : Completed
First Posted : June 17, 2009
Results First Posted : October 29, 2013
Last Update Posted : October 29, 2013
Sponsor:
Information provided by (Responsible Party):
FHI 360

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Healthy
Intervention Drug: levonorgestrel
Enrollment 72
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Levonorgestrel
Hide Arm/Group Description Only one study arm. All women were assigned to take 0.75 mg oral contraceptive pills (levonorgestrel) within 24 hours of engaging in sex.
Period Title: Overall Study
Started 72
Completed 68
Not Completed 4
Arm/Group Title Levonorgestrel
Hide Arm/Group Description 0.75 mg levonorgestrel oral contraceptive pills (levonorgestrel) : oral contraceptive pills
Overall Number of Baseline Participants 72
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 72 participants
32.4  (6.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants
Female
72
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Africa Number Analyzed 72 participants
72
1.Primary Outcome
Title Efficacy: the Pearl Index (Number of Pregnancies Per 100 Woman-years) in the Primary Evaluable Population (18-35)
Hide Description 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
Time Frame 6.5 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Levonorgestrel
Hide Arm/Group Description:
0.75 mg levonorgestrel oral contraceptive pills
Overall Number of Participants Analyzed 68
Measure Type: Number
Unit of Measure: pregnancies per 100 woman years
22.4
2.Primary Outcome
Title Participant Report of Adverse Events.
Hide Description 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
Time Frame 6.5 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Levonorgestrel Arm
Hide Arm/Group Description:
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 Number of Participants Analyzed 58
Measure Type: Number
Unit of Measure: adverse events
45
3.Secondary Outcome
Title Acceptability Based on Bleeding Patterns Reported
Hide Description Number of participants who reported bleeding patterns were acceptable and would therefore use Levonorgestrel
Time Frame 6.5 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Levonorgestrel Arm
Hide Arm/Group Description:
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 Number of Participants Analyzed 56
Measure Type: Number
Unit of Measure: participants
43
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Levonorgestrel Arm
Hide Arm/Group Description Only one study arm. All women were assigned to take 0.75 mg oral contraceptive pills (levonorgestrel) within 24 hours of engaging in sex.
All-Cause Mortality
Levonorgestrel Arm
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Levonorgestrel Arm
Affected / at Risk (%) # Events
Total   0/72 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Levonorgestrel Arm
Affected / at Risk (%) # Events
Total   28/72 (38.89%)    
Blood and lymphatic system disorders   
anemia   10/72 (13.89%)  11
Gastrointestinal disorders   
nausea   2/72 (2.78%)  2
vomiting   1/72 (1.39%)  1
General disorders   
irritability   1/72 (1.39%)  1
Immune system disorders   
hypersensitivity   1/72 (1.39%)  1
Infections and infestations   
Cellulitis   1/72 (1.39%)  1
chlamydial infection   1/72 (1.39%)  1
ear infection   1/72 (1.39%)  1
influenza   1/72 (1.39%)  1
rhinitis   1/72 (1.39%)  1
sinusitis   1/72 (1.39%)  1
tonsilitis   1/72 (1.39%)  1
upper respiratory tract infection   2/72 (2.78%)  2
urinary tract infections   1/72 (1.39%)  1
vaginal candidiasis   5/72 (6.94%)  5
Musculoskeletal and connective tissue disorders   
pain in extremity   1/72 (1.39%)  1
Nervous system disorders   
headache   3/72 (4.17%)  4
Renal and urinary disorders   
dysuria   1/72 (1.39%)  1
Reproductive system and breast disorders   
cervical dysplasia   1/72 (1.39%)  1
decereased libido   1/72 (1.39%)  1
vaginal discharge   3/72 (4.17%)  3
Respiratory, thoracic and mediastinal disorders   
cough   1/72 (1.39%)  1
Skin and subcutaneous tissue disorders   
dermititis allergic   1/72 (1.39%)  1
seborrhea   1/72 (1.39%)  1
Indicates events were collected by systematic assessment
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. Vera Halpern
Organization: FHI360
Phone: 9195447040
EMail: vhalpern@fhi360.org
Layout table for additonal information
Responsible Party: FHI 360
ClinicalTrials.gov Identifier: NCT00922233     History of Changes
Other Study ID Numbers: 10139
First Submitted: June 10, 2009
First Posted: June 17, 2009
Results First Submitted: May 24, 2013
Results First Posted: October 29, 2013
Last Update Posted: October 29, 2013