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| ID | Type | Description | Link |
|---|---|---|---|
| 38802 |
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The objectives of this study were to study the pharmacokinetics, pharmacodynamics and safety of Org 36286 after a single subcutaneous administration in healthy females.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Org 36286 15 μg + Lyndiol® | Experimental | After a pill-free period of 7 days, participants took 1 oral tablet of Lyndiol® (50 μg ethinylestradiol + 2.5 mg lynestrenol) daily for a total period of at least 6 weeks to suppress endogenous gonadotropin secretion. After 3 weeks of Lyndiol® intake, participants received a single subcutaneous dose of Org 36286 15 μg. |
|
| Org 36286 30 μg + Lyndiol® | Experimental | After a pill-free period of 7 days, participants took 1 oral tablet of Lyndiol® (50 μg ethinylestradiol + 2.5 mg lynestrenol) daily for a total period of at least 6 weeks to suppress endogenous gonadotropin secretion. After 3 weeks of Lyndiol® intake, participants received a single subcutaneous dose of Org 36286 30 μg. |
|
| Org 36286 60 μg + Lyndiol® | Experimental | After a pill-free period of 7 days, participants took 1 oral tablet of Lyndiol® (50 μg ethinylestradiol + 2.5 mg lynestrenol) daily for a total period of at least 6 weeks to suppress endogenous gonadotropin secretion. After 3 weeks of Lyndiol® intake, participants received a single subcutaneous dose of Org 36286 60 μg. |
|
| Org 36286 120 μg + Lyndiol® | Experimental | After a pill-free period of 7 days, participants took 1 oral tablet of Lyndiol® (50 μg ethinylestradiol + 2.5 mg lynestrenol) daily for a total period of at least 6 weeks to suppress endogenous gonadotropin secretion. After 3 weeks of Lyndiol® intake, participants received a single subcutaneous dose of Org 36286 120 μg. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Org 36286 | Drug | Subcutaneous Org 36286 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum number of follicles >= 5 mm (nmax) | Days 2 - 35 | |
| Mean dose-normalized maximum plasma concentration (Cmax) post single dose Org 36286 | Days 1 - 15 | |
| Mean dose-normalized area under the curve (AUC) post single dose Org 36286 | Days 1 - 15 | |
| Mean total plasma clearance (CL) post single dose Org 36286 | Days 1 - 15 | |
| Number of participants with an adverse event (AE) | Start of treatment up to day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Day on which the number of follicles >= 5 mm was equal to nmax for the first time (dmax) | Days 2 - 35 | |
| Total number of follicles >= 5 mm per day | Days 2 - 35 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C437186 | follicle stimulating hormone, human, with HCG C-terminal peptide |
| C002746 | Noracycline |
| D004997 | Ethinyl Estradiol |
| D008234 | Lynestrenol |
| ID | Term |
|---|---|
| D009651 | Norpregnatrienes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 | Steroids |
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| Lyndiol® | Drug | Lyndiol® (50 μg ethinylestradiol + 2.5 mg lynestrenol) tablets orally once a day for 6 weeks. |
|
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| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D042782 | Estrogenic Steroids, Alkylated |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009652 | Norpregnenes |