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

NCT02362373 | Completed Phase 4 Results

• 1 other identifier: AAAI0750
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Epilepsy; Contraception

Keywords

epilepsy; contraception; drug interaction

Outcome Measures

Primary Outcomes (3)

• Percent of Participants That Experienced Clinically Meaningful Change in Lamotrigine Level

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

  from baseline to 6 months after LNG IUS insertion

• Percent of Participants That Experienced Clinically Meaningful Change in Levetiracetam Level

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

  from baseline to 6 months after LNG IUS insertion

• Percent of Participants That Experienced Clinically Meaningful Change in Oxcarbazepine Level

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

  from baseline to 6 months after LNG IUS insertion

Secondary Outcomes (2)

• Change in Seizure Frequency

  baseline to 6 months

• Number of Participants Continuing With IUD

  6 months

Study Arms (1)

levonorgestrel IUS

OTHER

all women in the study underwent placement of the levonorgestrel IUS in an open-label fashion, outcomes were compared before and after placement.

Drug: levonorgestrel IUS

Interventions

levonorgestrel IUS DRUG

placement of levonorgestrel intrauterine system

Also known as: Mirena

levonorgestrel IUS

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Columbia University: lead
• Bayer: collaborator

Study Sites (1)

Columbia University

New York, New York, 10032, United States

Location

Related Publications (1)

• Vieira CS, Pack A, Roberts K, Davis AR. A pilot study of levonorgestrel concentrations and bleeding patterns in women with epilepsy using a levonorgestrel IUD and treated with antiepileptic drugs. Contraception. 2019 Apr;99(4):251-255. doi: 10.1016/j.contraception.2018.11.018. Epub 2018 Dec 4.

  PMID: 30529085 DERIVED

MeSH Terms

Conditions

Epilepsy

Interventions

Levonorgestrel

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Norgestrel; Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Anne Davis, MD
• Organization: Columbia University

ard4@cumc.columbia.edu

212-305-4951

Study Officials

• Anne Davis, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Obstetrics and Gynecology

Study Record Dates

• First Submitted: February 9, 2015
• First Posted: February 12, 2015
• Study Start: August 1, 2011
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: January 18, 2016
• Results First Posted: January 18, 2016

Record last verified: 2015-12

Locations

US (1)