Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Levomefolate Calcium · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | - |
| Arm 2 | ACTIVE_COMPARATOR | - |
| Arm 3 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Estradiol Valerate (EV) / Levomefolate Calcium (BAY98-7078) | DRUG | Oral, single dose, 3 mg EV + 0.451 mg levomefolate calcium, washout phase between treatments: at least 7 days |
| Estradiol Valerate (EV) (BAY86-4980) | DRUG | Oral, single dose, 3 mg EV, washout phase between treatments: at least 7 days |
| Levomefolate Calcium (BAY86-7660) | DRUG | Oral, single dose, 0.451 mg levomefolate calcium, washout phase between treatments: at least 7 days |
Inclusion Criteria: * BMI:\>18 \<30 kg/m² * Healthy female volunteers * Age 45-75 years * Postmenopausal state Exclusion Criteria: * Contraindications for use of combined (Estradiol Valerate/dienogest) contraceptive (e.g.history of venous/arterial thromboembolic disease) * Regular intake of medic...
Levomefolate Calcium is being investigated for use in contraception, specifically in combination with estradiol valerate for ovulation inhibition. It is a small molecule in Phase 1 clinical development, studied in a bioequivalence trial in Germany.
Levomefolate Calcium is being developed by Bayer AG, a German pharmaceutical company traded on the OTC market under the ticker BAYRY. The company is conducting clinical research on this compound for contraceptive applications.
Levomefolate Calcium is in Phase 1 clinical development. One Phase 1 trial has been completed, with no active trials currently ongoing. The drug is investigational and has not been approved for any use.
Levomefolate Calcium has one completed clinical trial, NCT01031355, a Phase 1 bioequivalence study comparing 3 mg estradiol valerate with and without levomefolate calcium. The trial enrolled 42 healthy female volunteers aged 45 years and older in Germany.
No, Levomefolate Calcium is not the same as estradiol valerate. They are distinct compounds being studied together in a combination product for contraception. The clinical trial evaluates the bioequivalence of estradiol valerate when administered with or without levomefolate calcium.