Trial Outcomes & Findings for Women With Epilepsy: a Pilot Study of PK and PD Anti-epileptic Drug Effects in Levonorgestrel Intrauterine System Users (NCT NCT02362373)

NCT ID: NCT02362373

Last Updated: 2016-01-18

Results Overview

The outcome measure is designed to examine whether participants will experience subtherapeutic or toxic serum trough level of lamotrigine after IUD insertion.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 20 participants
• Primary outcome timeframe: from baseline to 6 months after LNG IUS insertion
• Results posted on: 2016-01-18

Participant Flow

Participant milestones

Measure	Women With Epilepsy Receiving the LNG IUS There was one group in this pilot study. All women received the LNG IUS.
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Levonorgestrel IUS n=20 Participants 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
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age, Continuous	28 years STANDARD_DEVIATION 6.2 • n=93 Participants
Sex: Female, Male Female	20 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Region of Enrollment United States	20 participants n=93 Participants

PRIMARY outcome

Timeframe: from baseline to 6 months after LNG IUS insertion

Population: 13 out of 20 participants received lamotrigine while on IUD.

The outcome measure is designed to examine whether participants will experience subtherapeutic or toxic serum trough level of lamotrigine after IUD insertion.

Outcome measures

Measure	Women With Epilepsy Receiving the LNG IUS n=13 Participants There was one group in this pilot study. All women received the LNG IUS.
Percent of Participants That Experienced Clinically Meaningful Change in Lamotrigine Level	0 percentage of participants

PRIMARY outcome

Timeframe: from baseline to 6 months after LNG IUS insertion

Population: 5 out of 20 participants received levetiracetam while on IUD.

The outcome measure is designed to examine whether participants will experience subtherapeutic or toxic serum trough level of levetiracetam after IUD insertion.

Outcome measures

Measure	Women With Epilepsy Receiving the LNG IUS n=5 Participants There was one group in this pilot study. All women received the LNG IUS.
Percent of Participants That Experienced Clinically Meaningful Change in Levetiracetam Level	0 percentage of participants

PRIMARY outcome

Timeframe: from baseline to 6 months after LNG IUS insertion

Population: 3 out of 20 participants received oxcarbazepine while on IUD.

The outcome measure is designed to examine whether participants will experience subtherapeutic or toxic serum trough level of oxcarbazepine after IUD insertion.

Outcome measures

Measure	Women With Epilepsy Receiving the LNG IUS n=3 Participants There was one group in this pilot study. All women received the LNG IUS.
Percent of Participants That Experienced Clinically Meaningful Change in Oxcarbazepine Level	0 percentage of participants

SECONDARY outcome

Timeframe: baseline to 6 months

Number of participants with increased, unchanged or decreased mean monthly seizure frequency.

Outcome measures

Measure	Women With Epilepsy Receiving the LNG IUS n=20 Participants There was one group in this pilot study. All women received the LNG IUS.
Change in Seizure Frequency Seizure control unchanged	13 participants
Change in Seizure Frequency Seizure control decreased	3 participants
Change in Seizure Frequency Seizure control improved	4 participants

SECONDARY outcome

Timeframe: 6 months

Women continuing the IUD for contraception at 6 months

Outcome measures

Measure	Women With Epilepsy Receiving the LNG IUS n=20 Participants There was one group in this pilot study. All women received the LNG IUS.
Number of Participants Continuing With IUD	20 participants

Adverse Events

Women With Epilepsy Receiving the LNG IUS

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Women With Epilepsy Receiving the LNG IUS n=20 participants at risk There was one group in this pilot study. All women received the LNG IUS.
Reproductive system and breast disorders Ovarian cyst	10.0% 2/20 • Number of events 2
Reproductive system and breast disorders Uterine cramping	25.0% 5/20 • Number of events 5
Renal and urinary disorders urinary tract infection	10.0% 2/20 • Number of events 2
Gastrointestinal disorders Stomach pain	10.0% 2/20 • Number of events 2
General disorders Muscle spasms	10.0% 2/20 • Number of events 2
Respiratory, thoracic and mediastinal disorders Bronchitis	10.0% 2/20 • Number of events 2
Skin and subcutaneous tissue disorders acne	5.0% 1/20 • Number of events 1
General disorders common cold	5.0% 1/20 • Number of events 1
Reproductive system and breast disorders vaginal itching	10.0% 2/20 • Number of events 2
General disorders flu	5.0% 1/20 • Number of events 1
Reproductive system and breast disorders yeast infection	5.0% 1/20 • Number of events 1
Gastrointestinal disorders hemmorhoids	5.0% 1/20 • Number of events 1
General disorders sinus congestion	10.0% 2/20 • Number of events 2
Reproductive system and breast disorders bacterial vaginosis	10.0% 2/20 • Number of events 2
Cardiac disorders palpitations	5.0% 1/20 • Number of events 1
Renal and urinary disorders bladder spasms	5.0% 1/20 • Number of events 1
Musculoskeletal and connective tissue disorders hip injury	5.0% 1/20 • Number of events 1
Nervous system disorders headache	5.0% 1/20 • Number of events 1
Musculoskeletal and connective tissue disorders herniated disc	5.0% 1/20 • Number of events 1
Musculoskeletal and connective tissue disorders shoulder surgery	5.0% 1/20 • Number of events 1
Reproductive system and breast disorders pelvic pain	5.0% 1/20 • Number of events 1
General disorders seasonal allergies	5.0% 1/20 • Number of events 1
Nervous system disorders pinched nerve	5.0% 1/20 • Number of events 1
Infections and infestations strep throat	5.0% 1/20 • Number of events 1

Additional Information

Anne Davis, MD

Columbia University

Phone: 212-305-4951

Email: ard4@cumc.columbia.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place