Women With Epilepsy: a Pilot Study of PK and PD Anti-epileptic Drug Effects in Levonorgestrel Intrauterine System Users
| Status: | Completed |
|---|---|
| Conditions: | Contraception, Contraception, Neurology, Epilepsy |
| Therapuetic Areas: | Neurology, Other, Reproductive |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 4/21/2016 |
| Start Date: | August 2011 |
| End Date: | January 2014 |
Women With Epilepsy: a Pilot Study of Pharmacokinetic and Pharmacodynamic Anti-epileptic Drug Effects in Levonorgestrel Intrauterine System Users
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.
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.
Study Procedures This pilot study consists of five study visits. Once preliminary
eligibility is determined through a telephone screening interview, the first visit is
scheduled.
Visit 1 Enrollment/Baseline
- Review Eligibility
- Informed Consent
- Collect Baseline Information
- Vital Signs
- Pregnancy Test
- Complete Physical Exam including Pelvic exam,
- Chlamydia testing, and a Pap test if needed as per ASCCP (American Society for
Colposcopy and Cervical Pathology) guidelines
- Receive diary to record any bleeding or spotting
- Receive condoms, if needed, for use until IUS insertion
- Sign release for contact of primary neurologist or epileptologist
- Study MD to contact participant's neurologist to notify of trial participation, and
verify type and dose of AEDs
Visit 2 Insertion/4-6 Weeks from Baseline
- Vital Signs
- Pregnancy Test
- Phlebotomy for hormone and AED levels
- Transvaginal ultrasound
- IUS Insertion
- Review and collect completed diary
- Receive new diary
Visit 3/ Follow up 3 Weeks post IUS Insertion
- Vital Signs
- Phlebotomy for hormone and AED levels
- Transvaginal Ultrasound
- Review and collect completed diary
- Receive new diary
Visit 4/Follow up 3 Months post IUS Insertion
- Vital Signs
- Phlebotomy for hormone and AED levels
- Transvaginal ultrasound
- Review and collect completed diary
- Receive new diary
- Acceptability Questionnaire
Visit 5/ Exit 6 Months post IUS insertion
- Vital Signs
- Phlebotomy for hormone and AED levels
- Transvaginal Ultrasound
- Review and collect final completed diary
- Acceptability Questionnaire
eligibility is determined through a telephone screening interview, the first visit is
scheduled.
Visit 1 Enrollment/Baseline
- Review Eligibility
- Informed Consent
- Collect Baseline Information
- Vital Signs
- Pregnancy Test
- Complete Physical Exam including Pelvic exam,
- Chlamydia testing, and a Pap test if needed as per ASCCP (American Society for
Colposcopy and Cervical Pathology) guidelines
- Receive diary to record any bleeding or spotting
- Receive condoms, if needed, for use until IUS insertion
- Sign release for contact of primary neurologist or epileptologist
- Study MD to contact participant's neurologist to notify of trial participation, and
verify type and dose of AEDs
Visit 2 Insertion/4-6 Weeks from Baseline
- Vital Signs
- Pregnancy Test
- Phlebotomy for hormone and AED levels
- Transvaginal ultrasound
- IUS Insertion
- Review and collect completed diary
- Receive new diary
Visit 3/ Follow up 3 Weeks post IUS Insertion
- Vital Signs
- Phlebotomy for hormone and AED levels
- Transvaginal Ultrasound
- Review and collect completed diary
- Receive new diary
Visit 4/Follow up 3 Months post IUS Insertion
- Vital Signs
- Phlebotomy for hormone and AED levels
- Transvaginal ultrasound
- Review and collect completed diary
- Receive new diary
- Acceptability Questionnaire
Visit 5/ Exit 6 Months post IUS insertion
- Vital Signs
- Phlebotomy for hormone and AED levels
- Transvaginal Ultrasound
- Review and collect final completed diary
- Acceptability Questionnaire
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
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