Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Microgynon · 1 trial · 1 indication
AUC(0-inf) is defined as the area under the concentration-time curve from time 0 extrapolated to infinity and was calculated by using a non-compartmental analysis.
Cmax is defined as the maximum observed plasma concentration determined directly from the concentration-time data and was calculated by using a non-compartmental analysis.
| Arm | Type | Description |
|---|---|---|
| Combined Participants Group | EXPERIMENTAL | Participants received a dose of Microgynon \[0.03 mg Ethinyl Estradiol (EE)/0.15 mg Levonorgestrel (LNG)\] on Day 1 of Treatment Period 1. In Treatment Period 2, they received GSK3036656 40 mg on Day 4 followed by GSK3036656 20 mg once daily from Day 5 to Day 14. In Treatment Period 3, participants received Microgynon (EE/LNG) along with GSK3036656 20 mg on Day 15, followed by GSK3036656 20 mg once daily from Day 16 to Day 17. |
| Name | Type | Description |
|---|---|---|
| Microgynon | DRUG | Participants received 1 dose of Microgynon (0.03 mg EE/0.15 mg LNG) on Day 1 of Treatment Period 1 and 1 dose co-administered with GSK3036656 20 mg on Day 15 of Treatment Period 3. |
| GSK3036656 | DRUG | Participants received 1 loading dose of 40 mg on Day 4 and a dose of 20 mg on Days 5 to 14 once daily in Treatment Period 2. In Treatment Period 3, participants received one 20 mg dose along with Microgynon (0.03 mg EE/0.15 mg LNG) on Day 15 after which a 20 mg dose on Days 17 and 18 once daily. |
Inclusion Criteria: Age: 1. Participant was 18 to 65 years of age, inclusive, at the time of signing the informed consent. Type of Participant and Disease Characteristics: 2. Participants were healthy or compensated, as determined by the investigator or medically qualified designee, based on a...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Viatris, Inc. | VTRS | 1 | PHASE3 | Bedaquiline |
| Johnson & Johnson | JNJ | 1 | PHASE2 | Bedaquiline, Background Regimen |
| BioNTech SE Sponsored ADR | BNTX | 1 | PHASE1 | BNT164a1, BNT164b1 |
Microgynon is a combined oral contraceptive being studied in the context of tuberculosis. It is used in a clinical trial to investigate its pharmacokinetics when given alone and in combination with GSK3036656 in female participants of non-childbearing potential aged 18 to 65 years. The trial is not a treatment study for tuberculosis itself.
Microgynon is developed by GSK plc, a global pharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting research on this drug in the context of tuberculosis, specifically evaluating its interaction with another investigational drug in a pharmacokinetic study.
Microgynon is in Phase 1 clinical development. The completed trial, NCT06354257, was a Phase 1 study that has finished. Microgynon is an investigational drug in this context and is not yet approved for any use related to tuberculosis.
Microgynon has one completed clinical trial, NCT06354257, titled 'A Study to Investigate the Pharmacokinetics of a Combined Oral Contraceptive When Given Alone and in Combination With GSK3036656 in Female Participants of Non-childbearing Potential Aged 18 to 65 Years of Age.' The trial enrolled 20 female participants in Spain and was not randomized or double-blinded.
No, Microgynon is not the same as GSK3036656. Microgynon is a combined oral contraceptive, while GSK3036656 is a separate investigational drug. The clinical trial NCT06354257 studies the pharmacokinetics of Microgynon when given alone and in combination with GSK3036656 in female participants.