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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 Estradiol is a synthetic estrogen studied by GSK plc as part of a drug interaction assessment in infectious disease research. In this program it was evaluated for use alongside HIV and hepatitis treatments, specifically to determine how co-administration with another investigational agent affects its pharmacokinetics in healthy adult female subjects.
Ethinyl Estradiol targets ESR1, the estrogen receptor 1, and acts as an agonist at that receptor. By binding and activating ESR1, it produces estrogenic signaling, which underlies its use as the estrogen component of combined oral contraceptive products.
GSK plc, which trades under the ticker GSK, is the developer associated with this Ethinyl Estradiol program in infections, HIV and hepatitis. The work centers on evaluating the compound in a drug interaction study rather than as a standalone antiviral therapy.
Ethinyl Estradiol is in Phase 1 development for this infectious disease program. It is investigational in this setting and has not been approved for HIV or hepatitis use. The single Phase 1 trial has been completed, and no active trials are currently listed.
Ethinyl Estradiol was studied in one completed Phase 1 trial, NCT02159131, titled a study to evaluate the pharmacokinetics of an oral contraceptive containing levonorgestrel and ethinyl estradiol when co-administered with GSK1265744 in healthy adult female subjects. It enrolled 20 participants in the United Kingdom and was an uncontrolled, non-randomized, open-label design.