Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 3 of 393 for:    LEVONORGESTREL

Women With Epilepsy: a Pilot Study of PK and PD Anti-epileptic Drug Effects in Levonorgestrel Intrauterine System Users (WESAIL)

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: NCT02362373
Recruitment Status : Completed
First Posted : February 12, 2015
Results First Posted : January 18, 2016
Last Update Posted : January 18, 2016
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Anne Davis, Columbia University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label)
Conditions Epilepsy
Contraception
Intervention Drug: levonorgestrel IUS
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Women With Epilepsy Receiving the LNG IUS
Hide Arm/Group Description There was one group in this pilot study. All women received the LNG IUS.
Period Title: Overall Study
Started 20
Completed 20
Not Completed 0
Arm/Group Title Levonorgestrel IUS
Hide Arm/Group Description

all women in the study underwent placement of the levonorgestrel IUS in an open-label fashion, outcomes were compared before and after placement.

levonorgestrel IUS: placement of levonorgestrel intrauterine system

Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
<=18 years
0
   0.0%
Between 18 and 65 years
20
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
28  (6.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
20
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants
20
1.Primary Outcome
Title Percent of Participants That Experienced Clinically Meaningful Change in Lamotrigine Level
Hide Description The outcome measure is designed to examine whether participants will experience subtherapeutic or toxic serum trough level of lamotrigine after IUD insertion.
Time Frame from baseline to 6 months after LNG IUS insertion
Hide Outcome Measure Data
Hide Analysis Population Description
13 out of 20 participants received lamotrigine while on IUD.
Arm/Group Title Women With Epilepsy Receiving the LNG IUS
Hide Arm/Group Description:
There was one group in this pilot study. All women received the LNG IUS.
Overall Number of Participants Analyzed 13
Measure Type: Number
Unit of Measure: percentage of participants
0
2.Primary Outcome
Title Percent of Participants That Experienced Clinically Meaningful Change in Levetiracetam Level
Hide Description The outcome measure is designed to examine whether participants will experience subtherapeutic or toxic serum trough level of levetiracetam after IUD insertion.
Time Frame from baseline to 6 months after LNG IUS insertion
Hide Outcome Measure Data
Hide Analysis Population Description
5 out of 20 participants received levetiracetam while on IUD.
Arm/Group Title Women With Epilepsy Receiving the LNG IUS
Hide Arm/Group Description:
There was one group in this pilot study. All women received the LNG IUS.
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: percentage of participants
0
3.Primary Outcome
Title Percent of Participants That Experienced Clinically Meaningful Change in Oxcarbazepine Level
Hide Description The outcome measure is designed to examine whether participants will experience subtherapeutic or toxic serum trough level of oxcarbazepine after IUD insertion.
Time Frame from baseline to 6 months after LNG IUS insertion
Hide Outcome Measure Data
Hide Analysis Population Description
3 out of 20 participants received oxcarbazepine while on IUD.
Arm/Group Title Women With Epilepsy Receiving the LNG IUS
Hide Arm/Group Description:
There was one group in this pilot study. All women received the LNG IUS.
Overall Number of Participants Analyzed 3
Measure Type: Number
Unit of Measure: percentage of participants
0
4.Secondary Outcome
Title Change in Seizure Frequency
Hide Description Number of participants with increased, unchanged or decreased mean monthly seizure frequency.
Time Frame baseline to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Women With Epilepsy Receiving the LNG IUS
Hide Arm/Group Description:
There was one group in this pilot study. All women received the LNG IUS.
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: participants
Seizure control unchanged 13
Seizure control decreased 3
Seizure control improved 4
5.Secondary Outcome
Title Number of Participants Continuing With IUD
Hide Description Women continuing the IUD for contraception at 6 months
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Women With Epilepsy Receiving the LNG IUS
Hide Arm/Group Description:
There was one group in this pilot study. All women received the LNG IUS.
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: participants
20
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Women With Epilepsy Receiving the LNG IUS
Hide Arm/Group Description There was one group in this pilot study. All women received the LNG IUS.
All-Cause Mortality
Women With Epilepsy Receiving the LNG IUS
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Women With Epilepsy Receiving the LNG IUS
Affected / at Risk (%) # Events
Total   0/20 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Women With Epilepsy Receiving the LNG IUS
Affected / at Risk (%) # Events
Total   5/20 (25.00%)    
Cardiac disorders   
palpitations *  1/20 (5.00%)  1
Gastrointestinal disorders   
Stomach pain *  2/20 (10.00%)  2
hemmorhoids *  1/20 (5.00%)  1
General disorders   
Muscle spasms *  2/20 (10.00%)  2
common cold *  1/20 (5.00%)  1
flu *  1/20 (5.00%)  1
sinus congestion *  2/20 (10.00%)  2
seasonal allergies *  1/20 (5.00%)  1
Infections and infestations   
strep throat *  1/20 (5.00%)  1
Musculoskeletal and connective tissue disorders   
hip injury *  1/20 (5.00%)  1
herniated disc *  1/20 (5.00%)  1
shoulder surgery *  1/20 (5.00%)  1
Nervous system disorders   
headache *  1/20 (5.00%)  1
pinched nerve *  1/20 (5.00%)  1
Renal and urinary disorders   
urinary tract infection *  2/20 (10.00%)  2
bladder spasms *  1/20 (5.00%)  1
Reproductive system and breast disorders   
Ovarian cyst * [1]  2/20 (10.00%)  2
Uterine cramping *  5/20 (25.00%)  5
vaginal itching *  2/20 (10.00%)  2
yeast infection *  1/20 (5.00%)  1
bacterial vaginosis *  2/20 (10.00%)  2
pelvic pain *  1/20 (5.00%)  1
Respiratory, thoracic and mediastinal disorders   
Bronchitis *  2/20 (10.00%)  2
Skin and subcutaneous tissue disorders   
acne *  1/20 (5.00%)  1
*
Indicates events were collected by non-systematic assessment
[1]
One participant had a cyst that ruptured; conservative management was successful and no surgery was required.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Anne Davis, MD
Organization: Columbia University
Phone: 212-305-4951
Responsible Party: Anne Davis, Columbia University
ClinicalTrials.gov Identifier: NCT02362373     History of Changes
Other Study ID Numbers: AAAI0750
First Submitted: February 9, 2015
First Posted: February 12, 2015
Results First Submitted: December 14, 2015
Results First Posted: January 18, 2016
Last Update Posted: January 18, 2016