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

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Columbia University
• Collaborator: Bayer
• Treatments: Anticonvulsants; Levonorgestrel

Criteria

Inclusion Criteria:

1. Age18-45 years

2. Regular menstrual cycle of length 21-35 days

3. Willing to use IUS for contraception

4. Willing to use non-hormonal contraception for one month before insertion

5. Stable AED therapy for at least two months

6. Well-controlled epilepsy (2 or fewer seizures, other than simple partial, per month)

7. Working telephone

8. English Speaking

Exclusion Criteria:

1. Current pregnancy or pregnancy in the previous two months

2. Breastfeeding with amenorrhea

3. Hepatic p450 enzyme inducing medications other than AEDs (griseofulvin, rifampin, St. John's Wort, bosentan)

4. Depomedroxyprogesterone acetate within previous six months

5. Congenital or acquired uterine anomaly, including myomas, that distort the uterine cavity

6. Acute pelvic infection or a history pelvic infection without subsequent intrauterine pregnancy

7. Postpartum endometritis or infected abortion in the last three months

8. Genital bleeding of unknown etiology

9. Untreated lower genital tract infection (cervical or vaginal)

10. Acute liver disease or liver tumor, benign or malignant

11. HIV infection or partner with HIV infection

12. Increased susceptibility to pelvic infection

13. A previously inserted intrauterine device (IUD) that has not been removed

14. Hypersensitivity to any component of the LNG IUS

15. Known or suspected carcinoma of the breast

16. 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

17. History of genital tract malignancy

18. Current use of anti-coagulants

19. Current alcoholism or drug abuse