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

Completed · Phase 4

Conditions studied: Epilepsy, Contraception

In brief

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.

Key facts

Study ID

NCT02362373

Run by

Columbia University

People needed

20

Starts

2011-08-01

Expected to finish

2014-01-01

Last updated by the study team

2016-01-18

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Columbia University — New York, New York, United States

Full record on ClinicalTrials.gov

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