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Also known as SH T04769G
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 being developed as an oral contraceptive. It is a small molecule studied in a Phase 2 trial in healthy female volunteers aged 18 years and older. The trial evaluated a combined oral contraceptive containing SH T04769G and SH D00659AF for ovulation inhibition.
SH T is being developed by Bayer AG, which trades over the counter in the United States under the ticker BAYRY. Bayer sponsored the Phase 2 oral contraceptive trial of the drug.
SH T is in Phase 2 development. It is an investigational small molecule and has not been approved by the FDA for any indication. The Phase 2 trial of SH T has been completed.
SH T has been studied in one clinical trial, NCT00471991, titled Valette (Combined Oral Contraceptive SH T04769G and SH D00659AF) Low Ovulation Inhibition. This Phase 2 trial was completed, enrolled 60 participants, was randomized and active controlled, and was conducted in Germany.
Yes, SH T is also known as SH T04769G. The Phase 2 trial of the combined oral contraceptive lists the component as SH T04769G alongside SH D00659AF, so searches for either name refer to the same investigational compound.