Emergency contraception emergency contraception fertility control
Conditions
Interventions
The study will start with a inclusion visit. During the screening visit
standard medical assessments including safety laboratory tests (blood draw), a
physical examination and a vital signs measurem
Sponsors
HRA Pharma
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Women aged 28-45 years at screening;• No current use of hormonal contraception (including IUS) and having had at least 2 complete menstrual cycles (3 bleeding episodes) since having stopped hormonal contraception before baseline cycle ;• Not at risk of pregnancy: o not sexually active, or o willing to protect all further acts of intercourse with condoms, or o current use of Copper IUD o having undergone surgical sterilization (tubal ligation), or o partner sterilized or vasectomized ;• BMI
Exclusion criteria
Exclusion criteria: • Currently pregnant as confirmed by positive high-sensitivity urine pregnancy test ;• Currently breast-feeding;• Hypersensitivity to the active substance UPA or any of the excipients of the study treatment, namely lactose monohydrate, povidone K30, croscarmellose sodium and magnesium stearate;• Anomalies in safety labs done at screening visit recognized as clinically significant by the investigator;• Pap smear score >= 3 in the past 11 months;• Clinically significant abnormalities observed on TVU performed at screening visit ;• Cancer (past history of any carcinoma or sarcoma);• Chronic treatment with oral glucocorticoids ;• Hereditary galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption;• Known or suspected alcoholism or drug abuse;• Concomitant use of medication thought to interact with UPA (per SPCs);• Current participation in any other trial of an investigational medicine or participation in the month preceding the screening visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Follicular growth and the day of occurrence of ovulation during the treatment cycle | — |
Secondary
| Measure | Time frame |
|---|---|
| - Pharmacokinetic variables will be calculated for each subject and both analytes (UPA and 11-demethylated UPA) - Safety of treatment intake | — |
Countries
Netherlands
Outcome results
None listed