Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CDB-2914 · 3 trials · 2 indications
The rate of pregnancy in women who received emergency contraception within 72 h of unprotected sexual intercourse.
A high sensitivity pregnancy test was performed at inclusion (between 48h and 120h after unprotected intercourse) and then until menses occured or up to 60 days if they did not, at the following time points: * 5-7 days after expected date of menses * 1 week later * every two week after
Inhibition is calculated as the number of subjects exhibiting no dominant follicle rupture, divided by the total number of subjects having received treatment
| Arm | Type | Description |
|---|---|---|
| CDB-2914 | EXPERIMENTAL | - |
| Levonorgestrel | ACTIVE_COMPARATOR | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| CDB-2914 | DRUG | Single dose |
| Levonorgestrel | DRUG | Single dose |
| CDB-2914 (ulipristal acetate) | DRUG | single oral dose of 30 mg |
| Placebo | DRUG | single oral dose |
Inclusion Criteria: * women 16 or older in UK(except Northern Ireland) sites, 17 years or more in Northern Ireland (UK) and 18 years or more in Ireland and US * present within 120 hours of unprotected intercourse * regular menstrual cycles * No current use of hormonal contraception * Willing to not...
CDB-2914 is a small molecule being developed for contraception and emergency contraception. It is an investigational drug in Phase 3 clinical development, studied in women for these endocrine indications.
CDB-2914 is developed by Perrigo Company plc, traded on the stock exchange under the ticker PRGO. The company is conducting clinical trials to evaluate the drug for contraception and emergency contraception.
CDB-2914 is in Phase 3 clinical development. It is an investigational drug, not yet approved, and is being studied for contraception and emergency contraception in women.
CDB-2914 has completed two Phase 3 trials: NCT00411684, a safety and efficacy study for emergency contraception with 1623 participants, and NCT00551616, a comparison to levonorgestrel for contraception with 2221 participants. Both were randomized, double-blind, and placebo-controlled.
CDB-2914 is also known as ulipristal acetate, a selective progesterone receptor modulator. It is being developed for emergency contraception and contraception, and has been studied in clinical trials for these indications.