Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Levonorgestrel · 1 trial · 2 indications
AUC for each participant was calculated from all available LNG concentrations measured over 8 hours using the linear up/log down version of trapezoidal rule (i.e., noncompartmental technique) using the software package Phoenix WinNonLin (Certara®). This version of the trapezoidal rule used linear interpolation between untransformed data up to Cmax, and between log-transformed data from Cmax through Clast. Assay lower limit of quantification (LLOQ) for LNG was 0.025 ng/mL; values \< LLOQ were imputed as 0 (if pre-dose) or as 0.0125 (if post-dose).
| Arm | Type | Description |
|---|---|---|
| A: LNG 1.5 mg among participants on EFV-based ART (randomized) | EXPERIMENTAL | Participants received 1.5 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks. |
| B: LNG 3.0 mg among participants on EFV-based ART (randomized) | EXPERIMENTAL | Participants received 3mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks. |
| C: LNG 1.5 mg among participants on DTG-based ART (assigned) | EXPERIMENTAL | Participants received 1.5 mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks. |
| D: LNG 3.0 mg among participants on RIF-INH TB Therapy (assigned) | EXPERIMENTAL | Participants received 3mg of LNG once orally on Day 0 and were followed post-treatment for 4 weeks. |
| Name | Type | Description |
|---|---|---|
| Levonorgestrel (LNG) | DRUG | LNG tablet(s) were administered by mouth in a directly observed manner. |
Inclusion Criteria: * Postmenarcheal female. * Note: Participant report and clinician's opinion were acceptable. * The following laboratory values obtained within 30 days prior to study entry by any US laboratory that had a Clinical Laboratory Improvement Amendments (CLIA) certification or its e...
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Levonorgestrel is a small molecule being studied for use in HIV Infections, specifically as an emergency contraceptive in women taking efavirenz-based antiretroviral therapy or rifampicin-containing anti-tuberculosis therapy. It is currently in Phase 2 clinical development and is investigational, not yet approved for this use.
Levonorgestrel is a progestin hormone that works by binding to progesterone receptors, which prevents ovulation and fertilization. In the context of HIV Infections, it is being studied to evaluate its pharmacokinetics when combined with certain antiretroviral or anti-tuberculosis medications, which may affect its effectiveness as an emergency contraceptive.
Levonorgestrel is being developed by cbdMD, Inc., a company traded under the ticker YCBD. The company is conducting clinical research to evaluate the drug's use in HIV Infections, specifically in combination with other therapies.
Levonorgestrel is in Phase 2 clinical development for HIV Infections. It is an investigational drug and has not been approved by regulatory authorities for this indication. One Phase 2 trial has been completed, and no active trials are currently listed.
Levonorgestrel has one completed Phase 2 clinical trial, NCT03819114, titled 'Pharmacokinetic Study to Evaluate Double-Dose Levonorgestrel Emergency Contraception in Combination With Efavirenz-Based Antiretroviral Therapy or Rifampicin-Containing Anti-Tuberculosis Therapy.' The trial enrolled 122 female participants aged 16 years and older across multiple countries, including the United States, Botswana, Brazil, Kenya, Malawi, South Africa, and Thailand.