Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as CDB-2914 (ulipristal acetate)
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 an investigational small molecule developed by Perrigo Company plc (ticker: PRGO) for contraception and emergency contraception. It is also known as ulipristal acetate. The program is in Phase 3 clinical development and has been studied in randomized, double-blind, placebo-controlled trials.
CDB-2914 is being developed for contraception and emergency contraception. Clinical trials have evaluated it for preventing pregnancy after unprotected intercourse and for preventing follicular rupture after the luteinizing hormone surge. It is an investigational product and has not been approved by the FDA for these uses.
CDB-2914 is developed by Perrigo Company plc, which trades under the ticker PRGO. The company is the sponsor of the clinical development program for this small molecule in contraception and emergency contraception.
CDB-2914 is in Phase 3 clinical development. Two completed Phase 3 trials have evaluated its safety and efficacy, and a completed Phase 2 trial studied its effect on follicular rupture. It is an investigational drug and is not FDA approved.
CDB-2914 has been studied in completed trials including NCT00551616, a Phase 3 safety and efficacy study versus levonorgestrel for emergency contraception, NCT00411684, a Phase 3 safety and efficacy study for emergency contraception, and NCT01107093, a Phase 2 comparison versus placebo in the prevention of follicular rupture.
Yes, CDB-2914 is also known as ulipristal acetate. Both names refer to the same small molecule developed by Perrigo Company plc (ticker: PRGO) for contraception and emergency contraception. It is currently in Phase 3 clinical development.