Phase 4
N=20
Women With Epilepsy: a Pilot Study of PK and PD Anti-epileptic Drug Effects in Levonorgestrel Intrauterine System Users
Epilepsy · Contraception
Bottom Line
View on ClinicalTrials.gov: NCT02362373 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jan 2016
Primary outcome: Primary: Percent of Participants That Experienced Clinically Meaningful Change in Lamotrigine Level — 0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- levonorgestrel IUS (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Columbia University
- Primary completion
- Jan 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Participants That Experienced Clinically Meaningful Change in Lamotrigine Level |
— | — |
| PRIMARY Percent of Participants That Experienced Clinically Meaningful Change in Levetiracetam Level |
— | — |
| PRIMARY Percent of Participants That Experienced Clinically Meaningful Change in Oxcarbazepine Level |
— | — |
| SECONDARY Change in Seizure Frequency |
13; 3; 4 | — |
| SECONDARY Number of Participants Continuing With IUD |
20 | — |
Summary
The investigators will conduct a prospective, seven-month pilot study to explore pharmacokinetic (PK) and pharmacodynamic (PD) effects among women with epilepsy using the levonorgestrel intrauterine system (LNG IUS) for contraception. The investigators will enroll twenty women with well-controlled epilepsy maintained on stable anti-epileptic drugs (AED) therapy seeking the LNG IUS for contraception. The primary outcomes are AED levels and seizures before and after LNG IUS placement. Secondary outcomes include LNG levels, evidence of ovulation three weeks after insertion (serum progesterone >3ng/ml), bleeding and spotting, endometrial thickness, continuation, satisfaction and adverse events (removals, expulsions, side effects). The investigators will conduct a baseline month assessment, insertion visit, and follow-up visits at 21 days, three months and six months.
Eligibility Criteria
Inclusion Criteria
- Age18-45 years
- Regular menstrual cycle of length 21-35 days
- Willing to use IUS for contraception
- Willing to use non-hormonal contraception for one month before insertion
- Stable AED therapy for at least two months
- Well-controlled epilepsy (2 or fewer seizures, other than simple partial, per month)
- Working telephone
- English Speaking
Exclusion Criteria
- Current pregnancy or pregnancy in the previous two months
- Breastfeeding with amenorrhea
- Hepatic p450 enzyme inducing medications other than AEDs (griseofulvin, rifampin, St. John's Wort, bosentan)
- Depomedroxyprogesterone acetate within previous six months
- Congenital or acquired uterine anomaly, including myomas, that distort the uterine cavity
- Acute pelvic infection or a history pelvic infection without subsequent intrauterine pregnancy
- Postpartum endometritis or infected abortion in the last three months
- Genital bleeding of unknown etiology
- Untreated lower genital tract infection (cervical or vaginal)
- Acute liver disease or liver tumor, benign or malignant
- HIV infection or partner with HIV infection
- Increased susceptibility to pelvic infection
- A previously inserted intrauterine device (IUD) that has not been removed
- Hypersensitivity to any component of the LNG IUS
- Known or suspected carcinoma of the breast
- Current abnormal cervical cytology other than ASCUS or a history of abnormal cervical cytology other than ASCUS without appropriate follow-up demonstrating no evidence of disease
- History of genital tract malignancy
- Current use of anti-coagulants
- Current alcoholism or drug abuse
Data sourced from ClinicalTrials.gov (NCT02362373). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.