ot applicable

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

• Registration Number: EUCTR2011-005573-23-SE
• Lead Sponsor: aboratoire HRA Pharma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-19
• Last Update Posted: 30 September 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 85

Inclusion Criteria

•Healthy women aged 18-35 years old
•BMI < 30 Kg/m2
•Not at risk of pregnancy:
-not sexually active,
-willing to protect all further acts of intercourse with condoms until last study visit, or
-partner sterilized or vasectomized
•No use of progesterone-only-pill for 3 months before start of treatment cycle
•No use of implant hormonal contraception for 3 months before start of treatment cycle
•No use of levonorgestrel intrauterine system for 3 months before start of treatment cycle
•No use of depo provera for 12 months before start of treatment cycle
•Women must be able to and willing to give voluntary, written informed consent to participate in the study, and must agree to observe all study requirements

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 85
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Pregnant (positive urinary pregnancy test) or less than 4 weeks postpartum
•Currently breastfeeding
•Current use of an intra-uterine device (IUD)
•Use of any other hormonal contraception than the study medication during the treatment cycle
•Irregular menstrual cycles (before the onset of the contraceptive method for women under hormonal contraception at screening visit)
•Follicle-like structure (FLS) >13mm observed on transvaginal ultrasound (TVU) performed at baseline visit
•Dominant follicle size =13mm observed on TVU at day 18 (+/- 1 day) during the pre-treatment period
•Last Pap smear performed was abnormal (high-grade squamous intra-epithelial lesions or higher)
•Suspected hyperplasia or carcinoma of the endometrium
•Cancer (past history of any carcinoma or sarcoma)
•Known or suspected alcoholism or drug abuse
•Known abnormal thyroid status
•Chronic treatment with oral glucocorticoids
•Hereditary galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
•Known hypersensitivity to the ingredients of the test active substances or excipients namely, lactose monohydrate, povidone, croscarmellose sodium, magnesium stearate, maize starch, macrogol, calcium carbonate, glycerol, titanium dioxide, yellow ferric oxide pigment, montan glycol wax, talc
•Any contraindications to Microgynon 30® (per SPC) other than already listed (known hypertension (adequately controlled) or current elevated blood pressure >140/90; migraine with aura; current or history of confirmed venous thromboembolism; current or previous arterial thrombotic or embolic processes; known thrombogenic mutations; diabetes mellitus with vascular changes; sickle-cell anaemia; severe disturbances of liver function, active current hepatitis, previous or existing liver tumours; jaundice or persistent itching during a previous pregnancy; Dubin-Johnson syndrome; rotor syndrome; current or medically treated gallbladder disease; disorders of lipid metabolism; history of herpes gestationis, deterioration of otosclerosis during pregnancy)
•Concomitant use of medication thought to interact with ellaOne® or COCP during study participation
-Oral antidiabetics or insulin
-Concomitant use of the PGP substrates during study participation (e.g. alpha-methyldigoxin, amitriptyline, beta-acetyldigoxin, carbamazepine, cetirizine, chlorpromazine, citalopram, digoxin, doxepine, fexofenadine, glyburide, LAAM (Levo-Alpha Acetyl Methadol), morphine, nortriptyline, olanzapine, ondansetron, paroxetine, pentazocaine, phenobarbital, phenytoin, quetiapine, risperidone, sertraline, terfenadine, topiramate, trimipramine and venlafaxine)
-Concomitant use of liver enzyme inducers (e.g. rifampicin, phenytoin, Phenobarbital, carbamazepine, ritonavir, St John’s wort/ Hypericum perforatum) during study participation
-Concomitant use of potent liver enzyme inhibitors (e.g. ketoconazole, itraconazole, telithromycin, clarithromycin, nefazodone) during study participation
-Concomitant administration of medicinal products that increase gastric pH (e.g. proton pump inhibitors, antacids and H2-receptor antagonists) during study participation
•Current participation in any other trial of an investigational medicine or participation in the past three months before start of treatment cycle

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the study is to compare the effects of quick starting a Combined Oral Contraceptive Pill (COCP) on follicular growth and hormonal parameters after ellaOne® or placebo intake.;Secondary Objective: The secondary objective of the study is to compare the effects of quick starting a COCP on menstrual bleeding patterns and tolerability after ellaOne® or placebo intake;Primary end point(s): •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).<br>•Number of days of intake of COCP required to reach ovarian quiescence (Hoogland score =3) after the intake of ellaOne® or placebo.<br>;Timepoint(s) of evaluation of this end point: Hoogland scores will be calculated after 1 to 21 days of intake of COCP in both groups (preceded by the intake of ellaOne® or placebo).<br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Bleeding patterns during the intake of COCP, when started on the day after the intake of ellaOne® or placebo.<br>•Description and frequencies of adverse events.<br>;Timepoint(s) of evaluation of this end point: Bleeding patterns and adverse events will be collected throughout the study