Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04112095 | Adherence With Continuous-dose Oral Contraceptive: Evaluation of Self-Selection and Use | PHASE3 | COMPLETED | 962 | — | — | Sep 6, 2019 | Aug 5, 2021 | May 20, 2022 | 38 | United States |
| NCT03585712 | Effect of Norgestrel 75 mcg on Cervical Mucus and Ovarian Activity During Perfect Use, After One Delayed Intake and After a Missed Pill | PHASE2 | COMPLETED | 52 | — | — | Jul 24, 2018 | Apr 7, 2020 | Jun 3, 2021 | 2 | United States |
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...