Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ethinyl Estadiol · 1 trial · 1 indication
Blood samples will be collected to estimate the area under the concentration-time curve over the dosing interval (AUC\[0-tau\]) of LNG and EE following OC with and without 744
| Arm | Type | Description |
|---|---|---|
| OC containing levonorgestrel and ethinyl estradiol + GSK126574 | EXPERIMENTAL | Eligible subjects will enter a run-in-period of 21 days (may extend to 49 days) to stabilize on OC containing levonorgestrel and ethinyl estradiol in order to synchronize the menstrual cycles of multiple subjects. Subjects completing run-in-period will enter Treatment period 1 and will be dosed OC once daily on Days 1 to 10. At day 11 subjects will enter Treatment period 2 and will be dosed with OC containing levonorgestrel and ethinyl estradiol + 744 once daily on Day 12 to 19. Subjects completing Treatment period 2 will have 7 OC free days (Day 22 to 28) during which withdrawal menses should occur. Subjects will then be followed up for 7 to 14 days (Day 28 to 35/49). |
| Name | Type | Description |
|---|---|---|
| Ethinyl Estadiol | DRUG | EE is available as a combination of EE 0.03 mg and LNG 0.15mg, a monophasic oral contraceptive tablet to be taken along with 240 mL water |
| Levonorgestrel | DRUG | LNG is available as a combination of EE 0.03 mg and LNG 0.15mg, a monophasic oral contraceptive tablet to be taken along with 240 mL water |
| GSK1265744 | DRUG | GSK1265744 is available as 30 mg tablet to be taken along with 240 mL water |
Inclusion Criteria: * Healthy female subjects, as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. * Females aged between 18 and 45 years of age inclusive, at the time of si...
Ethinyl Estadiol is a small molecule being studied in the context of infections, specifically Human Immunodeficiency Virus and Hepatitis. It is currently in Phase 1 clinical development as an investigational drug. The drug is being evaluated in a clinical trial that assesses its pharmacokinetics when co-administered with another medication in healthy adult female subjects.
Ethinyl Estadiol is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical research on this drug for infectious disease indications, including Human Immunodeficiency Virus and Hepatitis.
Ethinyl Estadiol is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The drug is being studied for its safety and pharmacokinetic profile in a Phase 1 clinical trial that has been completed.
Ethinyl Estadiol has one completed Phase 1 clinical trial registered under NCT02159131. The trial, titled 'Study to Evaluate the Pharmacokinetics of an Oral Contraceptive Containing Levonorgestrel and Ethinyl Estradiol When Co-administered With GSK1265744 in Healthy Adult Female Subjects,' enrolled 20 participants in the United Kingdom. The study was uncontrolled and not randomized or double-blinded.
Ethinyl Estadiol is a variant spelling of Ethinyl Estradiol, a synthetic form of estrogen used in oral contraceptives. In the clinical trial data, the drug is referred to as Ethinyl Estradiol, and it is being studied in combination with levonorgestrel for potential interactions with another investigational drug.