Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication Use To prevent pregnancy FDA label
Norgestrel · 2 trials · 1 indication
Measurement tool: interview
Measurement tool: electronic diary
Measurement tool: electronic diary
Measurement tool: electronic diary
Difference in Cervical Mucus Score between baseline (as Day 41 or Day 69) and delayed (Day 42 and Day 70) or missed pill (Day 43 or day 71) The Insler cervical mucus score (0-12) is the sum of 4 subscores: * viscosity from 0 (thick, highly viscous) to 3 (watery,minimally viscous) * ferning from 0 (no crystallization) to 3 (tertiary and quaternary stem ferning) * spinnbarkeit from 0 (\<1 cm) to 3 (\>= 9 cm) * rank for cells from 0 (\>20 cells per High Power Field or \>1000 cells per μL) to 3 (0 cell) A score \<5 is considered as a protective score while a score \>9 is considered as a non protective score
| Arm | Type | Description |
|---|---|---|
| Use Phase Norgestrel 0.075 mg | EXPERIMENTAL | Norgestrel 0.075 mg tablets to be taken orally, one tablet daily at the same time every day for up to 24 weeks |
| Arm A: Delayed then Missed Pill | OTHER | Treatment period 2, Day 42 +/- 3 days: 6 hour delayed intake of Norgestrel 75 mcg Treatment period 3, Day 70 +/- 3 days: missed pill of Norgestrel 75 mcg |
| Arm B: Missed then Delayed Pill | OTHER | Treatment period 2, Day 42 +/- 3 days: missed pill of Norgestrel 75 mcg Treatment period 3, Day 70 +/- 3 days: 6 hour delayed intake of the pill of Norgestrel 75 mcg |
| Name | Type | Description |
|---|---|---|
| Norgestrel 0.075 mg tablets | DRUG | All subjects enrolled in the use phase of this open-label study will be given the opportunity to purchase and take one Norgestrel 0.075 mg tablet daily up to 24 weeks. Subjects will use the investigational product based on their understanding of the directions on the outer packaging called the Drug Facts Label and information inside the product packaging called the Consumer Information Leaflet. |
| Norgestrel 0.075 mg | DRUG | Subjects will take norgestrel 75 mcg every day at the same time for three 28-day treatment periods, except for 1 specific day during treatment period 2 and treatment period 3 |
Inclusion Criteria: * Women who are willing to purchase (in the pharmacies) or be provided (in the clinics, for women younger than 18 years old) oral contraception for their own use for the purposes of the study Exclusion Criteria: * Cannot read, speak and understand English * Cannot see well eno...
Norgestrel is used for contraception. It is a small molecule progestin developed by Perrigo Company plc (ticker: PRGO) as an oral contraceptive. The clinical program has studied continuous-dose oral contraceptive use in female participants, including a Phase 3 trial in the United States.
Norgestrel works as an agonist at the progesterone receptor (PGR). By binding to and activating PGR, it produces progestogenic effects that support contraceptive activity. This mechanism underlies its development as a progestin-only oral contraceptive for preventing pregnancy.
Norgestrel is developed by Perrigo Company plc, which trades under the ticker PRGO. Perrigo is the sponsor of the clinical trials evaluating norgestrel 0.075 mg tablets for contraception.
Norgestrel is in Phase 3 clinical development for contraception. Two trials have been completed, including one Phase 3 study and one Phase 2 study, with a combined enrollment of 1,014 participants. No active trials are currently listed.
Norgestrel has been studied in two completed clinical trials. NCT04112095 was a Phase 3 trial of adherence with continuous-dose oral contraceptive in 962 female participants. NCT03585712 was a Phase 2 trial evaluating the effect of norgestrel 75 mcg on cervical mucus and ovarian activity in 52 female participants.