Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Bayer | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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
Visit 2 Insertion/4-6 Weeks from Baseline
Visit 3/ Follow up 3 Weeks post IUS Insertion
Visit 4/Follow up 3 Months post IUS Insertion
Visit 5/ Exit 6 Months post IUS insertion
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| levonorgestrel IUS | Drug | placement of levonorgestrel intrauterine system |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Seizure Frequency | Number of participants with increased, unchanged or decreased mean monthly seizure frequency. | baseline to 6 months |
| Number of Participants Continuing With IUD | Women continuing the IUD for contraception at 6 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Anne Davis, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30529085 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Women With Epilepsy Receiving the LNG IUS | There was one group in this pilot study. All women received the LNG IUS. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Levonorgestrel IUS | all women in the study underwent placement of the levonorgestrel IUS in an open-label fashion, outcomes were compared before and after placement. levonorgestrel IUS: placement of levonorgestrel intrauterine system |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 13 out of 20 participants received lamotrigine while on IUD. | Posted | Number | percentage of participants | from baseline to 6 months after LNG IUS insertion |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Women With Epilepsy Receiving the LNG IUS | There was one group in this pilot study. All women received the LNG IUS. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ovarian cyst | Reproductive system and breast disorders | Non-systematic Assessment | One participant had a cyst that ruptured; conservative management was successful and no surgery was required. |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anne Davis, MD | Columbia University | 212-305-4951 | ard4@cumc.columbia.edu |
Not provided
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D016912 | Levonorgestrel |
| ID | Term |
|---|---|
| D009644 | Norgestrel |
| D009652 | Norpregnenes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 6 months |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Primary | 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. | 5 out of 20 participants received levetiracetam while on IUD. | Posted | Number | percentage of participants | from baseline to 6 months after LNG IUS insertion |
|
|
|
| Primary | 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. | 3 out of 20 participants received oxcarbazepine while on IUD. | Posted | Number | percentage of participants | from baseline to 6 months after LNG IUS insertion |
|
|
|
| Secondary | Change in Seizure Frequency | Number of participants with increased, unchanged or decreased mean monthly seizure frequency. | Posted | Number | participants | baseline to 6 months |
|
|
|
| Secondary | Number of Participants Continuing With IUD | Women continuing the IUD for contraception at 6 months | Posted | Number | participants | 6 months |
|
|
|
| 0 |
| 20 |
| 5 |
| 20 |
|
| Uterine cramping | Reproductive system and breast disorders | Non-systematic Assessment |
|
| urinary tract infection | Renal and urinary disorders | Non-systematic Assessment |
|
| Stomach pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Muscle spasms | General disorders | Non-systematic Assessment |
|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| acne | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| common cold | General disorders | Non-systematic Assessment |
|
| vaginal itching | Reproductive system and breast disorders | Non-systematic Assessment |
|
| flu | General disorders | Non-systematic Assessment |
|
| yeast infection | Reproductive system and breast disorders | Non-systematic Assessment |
|
| hemmorhoids | Gastrointestinal disorders | Non-systematic Assessment |
|
| sinus congestion | General disorders | Non-systematic Assessment |
|
| bacterial vaginosis | Reproductive system and breast disorders | Non-systematic Assessment |
|
| palpitations | Cardiac disorders | Non-systematic Assessment |
|
| bladder spasms | Renal and urinary disorders | Non-systematic Assessment |
|
| hip injury | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| headache | Nervous system disorders | Non-systematic Assessment |
|
| herniated disc | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| shoulder surgery | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| pelvic pain | Reproductive system and breast disorders | Non-systematic Assessment |
|
| seasonal allergies | General disorders | Non-systematic Assessment |
|
| pinched nerve | Nervous system disorders | Non-systematic Assessment |
|
| strep throat | Infections and infestations | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
|