Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Microgestin · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Part 1: Healthy Volunteers | EXPERIMENTAL | Microgestin® (EE 30 μg and NET 1500 μg) single dose (Day 1). After a 10-14 day washout, Microgestin® single dose (Day 14) PLUS IW-3718 1500 mg twice daily (Days 13 to 19). |
| Part 2: Healthy Volunteers | EXPERIMENTAL | Levothyroxine 600 μg single dose (Day 1). After a 35-39 day washout, levothyroxine 600 μg single dose (Day 39) PLUS IW-3718 1500 mg twice daily (Days 38 to 41). |
| Part 3: Healthy Volunteers | EXPERIMENTAL | Phase 1: Glyburide 5 mg single dose (Day 1). After a 7-10 day washout, glyburide 5 mg single dose (Day 11) PLUS IW-3718 1500 mg twice daily (ie, Days 10 to 14). Phase 2: Digoxin 0.25 mg single dose (Day 23). After a 10-14 day washout, digoxin 0.25 mg mg single dose (Day 35) PLUS IW-3718 1500 mg twice daily (Days 34 to 42). |
| Name | Type | Description |
|---|---|---|
| Microgestin® | DRUG | 30 μg/1500 μg tablets for oral administration |
| Levothyroxine | DRUG | 600 μg tablets for oral administration |
| Glyburide | DRUG | 5 mg tablets for oral administration |
| Digoxin | DRUG | 0.25 mg tablets for oral administration |
| IW-3718 | DRUG | 500-mg film-coated tablets for oral administration |
Inclusion Criteria: * Is healthy, ambulatory, and 18-50 years of age (inclusive) at screening visit. * Weighs at least 50 kg and has a body mass index within 18-35 kg/m2 at the screening visit. * Is not pregnant or breastfeeding at the time of the screening visit and has negative serum pregnancy te...
Microgestin is an oral contraceptive referenced as a comparator medication in a Phase 1 drug interaction study. In that trial, Microgestin was given to healthy adult volunteers to evaluate whether an investigational compound affects its pharmacokinetics. The study has been completed.
Microgestin is associated with Ironwood Pharmaceuticals, Inc., which trades under the ticker IRWD. Ironwood is the developer linked to the clinical program in which Microgestin was studied as an oral contraceptive probe. The company sponsored the Phase 1 pharmacokinetic interaction trial conducted in the United States.
Microgestin was evaluated in a Phase 1 clinical trial. That study, NCT03856970, has been completed. It enrolled 87 healthy adult volunteers and was a controlled pharmacokinetic drug interaction study. The trial was not randomized and was not double blinded.
Microgestin was studied in one clinical trial, NCT03856970, titled a study to evaluate the effect of IW-3718 on the pharmacokinetics of oral contraceptive, levothyroxine, glyburide, and digoxin in healthy adult volunteers. The Phase 1 trial was completed, enrolled 87 participants, and took place in the United States.
Yes. Microgestin and Microgestin® refer to the same product. The registered trademark symbol is simply a notation of the brand name. Both forms of the name point to the oral contraceptive used as a comparator in the completed Phase 1 pharmacokinetic interaction study.