Emergency contraception
Conditions
Interventions
Trade Name: ellaOne
Product Name: ellaOne
Pharmaceutical Form: Tablet
INN or Proposed INN: ulipristal acetate
CAS Number: 126784-99-4
Other descriptive name: ULIPRISTAL ACETATE
Concentration unit: mg
Sponsors
HRA Pharma
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To explore the pharmacodynamic (PD) effects, and specifically on occurrence and timing of ovulation with pregnancy risk, of ellaOne taken after pills of combined oral contraception (COC) were missed for three consecutive days during the first week of COC use and were resumed either on the day of ellaOne intake or five days later.;Secondary Objective: To explore in the 5 days after ellaOne intake the PD effects on ovarian activity (particularly ovulation risk) of ellaOne taken after 3 consecutive COC pills missed in 1st week of use then resumed on ellaOne intake day or 5 days later To show ovarian activity (particularly occurrence and timing of ovulations) in baseline period (BAS); assess similarity level with experimental period (EXP) where women missed 3 COC pills, took ellaOne, resumed COC on ellaOne intake day or 5 days later To evaluate ovarian quiescence (OQ) duration &proportion of women with OQ over the 28-day BAS To evaluate OQ duration and proportion of women with OQ over the 28-day EXP where women missed 3 COC pills, took ellaOne, resumed COC on ellaOne intake day or 5 days later; with specific attention to 5 days after ellaOne intake To evaluate safety (specifically effects on spotting and vaginal bleeding) of ellaOne taken after 3 COC pills missed in 1st week of use then resumed on ellaOne intake day or 5 days later;Primary end point(s): a. Ovarian Activity Score (quiescence, ovarian activity, ovulation at risk of pregnancy) b.Occurrence of ovulation with risk of pregnancy c.Time to ovulation with risk of pregnancy ;Timepoint(s) of evaluation of this end point: Follicular diameter and levels of hormones in serum will be measured throughout baseline, experimental and post-experimental periods Ovulation at risk of pregnancy will be defined as: a. A postovulatory image is observed on transvaginal ultrasound. It is defined as follow: Image observed after abrupt disappearance of FLS OR Image observed after reduction in size of the leading fol | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety of treatment intake;Timepoint(s) of evaluation of this end point: Analysis of spotting / vaginal bleeding under treatment and occurrence of adverse events. Vital signs and laboratory safety parameters will also be described by quantitative statistics, at each time point | — |
Countries
Germany
Contacts
Public ContactHelene Lincker
HRA Pharma
Outcome results
None listed