Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SH T · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Arm 1 | ACTIVE_COMPARATOR | - |
| Arm 2 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| SH T04769G | DRUG | The study consists of 4 cycles resulting in approx. 16 weeks of study participation. The investigational product is an oral contraceptive. 21 tablets are taken each cycle followed by a 7-day tablet-free interval. (One cycle lasts for 28 days.)Volunteers will have to come for a visit every 2 to 4 days over the whole study period.The function of the ovaries is studied by transvaginal ultrasonography and determination of hormonal parameters from blood samples. The mouth of the uterus is inspected during each visit and the cervical smear will be investigated. Adverse events will be recorded and diary entries will be controlled by the investigator. |
| Ethinyl estradiol / dienogest (SH D00659 AF) | DRUG | The study consists of 4 cycles resulting in approx. 16 weeks of study participation. The investigational product is an oral contraceptive. 21 tablets are taken each cycle followed by a 7-day tablet-free interval. (One cycle lasts for 28 days.)Volunteers will have to come for a visit every 2 to 4 days over the whole study period.The function of the ovaries is studied by transvaginal ultrasonography and determination of hormonal parameters from blood samples. The mouth of the uterus is inspected during each visit and the cervical smear will be investigated. Adverse events will be recorded and diary entries will be controlled by the investigator.Volunteers have to undergo a series of blood sampling during the 2nd treatment cycle to evaluate the pharmacokinetic (liberation, absorption, distribution, metabolization and excretion) of the new oral contraceptive. |
Inclusion Criteria: * Healthy female volunteers, aged 18 - 35 years (smokers up to 30 years) * Willingness to apply non-hormonal methods of contraception during the course of the study (e.g., condom with spermicide, diaphragm with spermicide) * Confirmation of ovulation during the cycle before trea...
SH T is an investigational small molecule being developed as an oral contraceptive. It is currently in Phase 2 clinical development, with one completed trial evaluating its ovulation inhibition effects in healthy female volunteers.
SH T is being developed by Bayer AG, a pharmaceutical company traded on the OTC market under the ticker BAYRY. The drug is currently in Phase 2 clinical development for use as an oral contraceptive.
SH T is in Phase 2 clinical development. It has completed one Phase 2 trial, NCT00471991, which evaluated its ovulation inhibition properties in healthy female volunteers. The drug is investigational and not yet approved for any use.
SH T has one completed clinical trial, NCT00471991, titled 'Valette (Combined Oral Contraceptive SH T04769G and SH D00659AF) Low Ovulation Inhibition'. This Phase 2 study enrolled 60 healthy female participants aged 18 years and older in Germany.
SH T is a component of the combined oral contraceptive Valette, which also contains SH D00659AF. The clinical trial NCT00471991 evaluated the ovulation inhibition of this combination, with SH T being one of the active ingredients.