ot applicable

Phase 1

• Conditions: Emergency contraception; Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

• Registration Number: EUCTR2017-002283-41-DE
• Lead Sponsor: HRA Pharma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-11
• Last Update Posted: 23 July 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

•Women aged 18-30 years old at screening
•Women relying on a COC (containing 30 µg ethinyl estradiol and 7-day pill-free (or placebo) interval) as their primary method of contraception for at least 2 cycles before they enter the baseline period and willing to continue with a COC for at least one cycle after end of experimental period
•Not at risk of pregnancy:
onot sexually active, or
owilling to protect all acts of intercourse with condoms, or
ohaving undergone surgical sterilization (tubal ligation), or
opartner sterilized or vasectomized
•BMI < 30.0 kg/m2
•Women able to give informed consent form to participate in the study and willing to comply with all study constraints

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Currently pregnant as confirmed by positive high-sensitivity urine pregnancy test
• Currently breast-feeding
• Current use of an IUD
• Use of any hormonal contraception other than the study medications during the study
• Liver enzymes levels at the screening visit above three times the upper limit of normal or any other anomalies in safety labs recognized as clinically significant by the investigator
• Known hypersensitivity to the ingredients of the test active substances or excipients
• Any contraindications to Levora® (per SPC)
• Pap smear score = 3 in the past 11 months
• Known Polycystic Ovary Syndrome (PCOS)
• Clinically significant abnormalities observed on TVU performed at screening visit
• Cancer (past history of any carcinoma or sarcoma)
• Known abnormal thyroid status not adequately stabilized or substituted by current treatment
• 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 ellaOne® or Levora® (per SPCs)
• Current participation in any other trial of an investigational medicine or participation in the past three months before start of baseline period

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified