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The purposes of this study are to compare the effects on ovarian activity of quick starting a Combined Oral Contraceptive Pill (COCP) after ellaOne® or placebo intake.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ellaOne + microgynon 30 | Experimental |
| |
| placebo + microgynon 30 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ulipristal Acetate (UPA) + ethinylestradiol/levonorgestrel (Microgynon) | Drug | UPA: 30 mg, 1 tablet, single intake Microgynon 30mcg/150mcg, 1 tablet per day, 21-day intake |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with a Hoogland score consistent with ovarian quiescence (≤3) after 1 to 21 days of intake of COCP in both groups (preceded by the intake of ellaOne® or placebo). | Day 1 to day 21 of intake of microgynon 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of days of intake of COCP required to reach ovarian quiescence (Hoogland score ≤3) after the intake of ellaOne® or placebo. | Day 1 to day 21 of intake of microgynon 30 |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sharon Cameron, MD | Chalmers Sexual Health Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dinox | Groningen | 9713 | Netherlands | |||
| Karolinska University Hospital Solna |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25994664 | Derived | Cameron ST, Berger C, Michie L, Klipping C, Gemzell-Danielsson K. The effects on ovarian activity of ulipristal acetate when 'quickstarting' a combined oral contraceptive pill: a prospective, randomized, double-blind parallel-arm, placebo-controlled study. Hum Reprod. 2015 Jul;30(7):1566-72. doi: 10.1093/humrep/dev115. Epub 2015 May 20. |
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|
| placebo + ethinylestradiol/levonorgestrel | Drug | placebo: 1 tablet, single intake Microgynon 30mcg/150mcg, 1 tablet per day, 21-day intake |
|
|
| Stockholm |
| SE-171 76 |
| Sweden |
| Chalmers Sexual Health Clinic | Edinburgh | Scotland | EH3 9ES | United Kingdom |
| ID | Term |
|---|---|
| C555622 | ulipristal acetate |
| D004997 | Ethinyl Estradiol |
| D016912 | Levonorgestrel |
| C072593 | ethinyl estradiol, levonorgestrel drug combination |
| ID | Term |
|---|---|
| D009651 | Norpregnatrienes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 | Steroids |
| 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 |
| D009644 | Norgestrel |
| D009652 | Norpregnenes |
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