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Desogestrel/ethinyl estradiol and ethinyl estradiol · 2 trials · 6 indications
Normal range for this hemostatic parameter was 41 to 372 pmol/L. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.
| Arm | Type | Description |
|---|---|---|
| Treatment I: (DR-102) | EXPERIMENTAL | 21 days of combination active pills (containing 150 mcg desogestrel \[DSG\]/20 mcg ethinyl estradiol \[EE\]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles |
| Treatment II | ACTIVE_COMPARATOR | 21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles |
| 28-day Desogestrel Oral Contraceptive | EXPERIMENTAL | - |
| 28-day Drospirenone Oral Contraceptive | ACTIVE_COMPARATOR | - |
| 28-day Levonorgestrel Oral Contraceptive | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| desogestrel/ethinyl estradiol and ethinyl estradiol | DRUG | - |
| desogestrel/ethinyl estradiol | DRUG | - |
| 28-day drospirenone oral contraceptive | DRUG | Drospirenone/ethinyl estradiol 0.3/0.02 mg |
| 28-day levonorgestrel oral contraceptive | DRUG | Levonorgestrel/ethinyl estradiol 0.1/0.02 mg |
Inclusion Criteria: * Premenopausal, non-pregnant, non-lactating women age 18-40 years old * Body Mass Index (BMI) ≥18 kg/m² and \<30 kg/m² * Regular spontaneous menstrual cycle * Others as dictated by FDA-approved protocol Exclusion Criteria: * Any condition which contraindicates the use of comb...
Desogestrel/ethinyl estradiol and ethinyl estradiol is an oral contraceptive combination developed by Teva Pharmaceutical Industries Limited. It is a small molecule product studied in healthy women for contraceptive use, with research also examining its effects on follicle development and hemostatic parameters. It is investigational and has been evaluated in clinical trials rather than being described as approved.
Desogestrel/ethinyl estradiol and ethinyl estradiol targets the progesterone receptor, or PGR, acting as an agonist. Progestin components in oral contraceptives work through progesterone receptor agonism to suppress ovulation and influence the endometrium and cervical mucus, which supports the contraceptive effect studied in the clinical program.
Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA, is the developer of desogestrel/ethinyl estradiol and ethinyl estradiol. Teva is a multinational pharmaceutical company, and this oral contraceptive combination is part of its women's health development activity.
Desogestrel/ethinyl estradiol and ethinyl estradiol is in Phase 1 development. One Phase 1 trial has been completed, and a related Phase 2 study has also been completed. The program is investigational and is not described as FDA approved.
Desogestrel/ethinyl estradiol and ethinyl estradiol has been studied in two completed trials. NCT01291004 was a Phase 1 study of ovarian follicular activity and hormone levels in the United States with 206 participants. NCT01388491 was a Phase 2 multinational study of hemostatic parameters in healthy women with 293 participants across Germany, Israel, Italy, and Spain.
Desogestrel/ethinyl estradiol and ethinyl estradiol is being studied as an oral contraceptive in healthy women. Clinical research has evaluated its effects on follicle development and ovarian follicular activity, as well as on hemostatic parameters, which are blood clotting measures relevant to contraceptive safety assessment.