Contraception
Conditions
Interventions
Trade Name: ellaOne
Product Name: ellaOne
Pharmaceutical Form: Tablet
INN or Proposed INN: Ulipristal acetate
CAS Number: 126784-99-4
Current Sponsor code: VA2914 – CDB-2914
Other descriptive name: UL
Sponsors
Laboratoire HRA Pharma
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Healthy women aged 18-35 years old •BMI =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). •Number of days of intake of COCP required to reach ovarian quiescence (Hoogland score =3) after the intake of ellaOne® or placebo. ;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). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Bleeding patterns during the intake of COCP, when started on the day after the intake of ellaOne® or placebo. •Description and frequencies of adverse events. ;Timepoint(s) of evaluation of this end point: Bleeding patterns and adverse events will be collected throughout the study | — |
Countries
Netherlands, Sweden, United Kingdom
Contacts
Public ContactDr Sharon Cameron
Chalmers Sexual Health Clinic
Outcome results
None listed