Contraception MedDRA version: 20.0 Level: PT Classification code 10030970 Term: Oral contraception System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Product Name: Estelle
Product Code: 15 mg estetrol (E4) / 3 mg drospirenone (DRSP)
Pharmaceutical Form: Tablet
INN or Proposed INN: Estetrol
Sponsors
Estetra SPRL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Heterosexually active female at risk for pregnancy and requesting contraception. 2. Negative serum pregnancy test at subject enrollment. 3. Aged 18 to 50 years (inclusive) at the time of signing the informed consent (IC). 4. Willing to use the investigational product as the primary method of contraception for 13 consecutive cycles. 5. Good physical and mental health on the basis of medical, surgical and gynecological history, physical examination, gynecological examination, clinical laboratory, and vital signs. 6. Body mass index (BMI) below or equal to (=) 35 kg/m2. 7. Able to fulfill the requirements of the protocol and have indicated a willingness to participate in the study by providing written IC. 8. Willing and able to complete the diaries and questionnaires. For the endometrial safety sub-study: 9. Subset of subjects from the main study willing to participate in the endometrial safety sub-study by giving their consent for the endometrial safety sub-study. 10. Endometrial biopsy taken at screening that reveals no abnormal results, i.e. presence of hyperplasia (simple or complex, with or without atypia) or presence of carcinoma. 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 1550 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. For subjects who are not using hormonal contraception at screening, a menstrual cycle length shorter than 21 days or longer than 35 days. 2. Clinically relevant abnormal laboratory result at screening in the opinion of the investigator with an understanding of the central laboratory normal range 3. Known hypersensitivity to any of the investigational product ingredients 4. Currently pregnant or wth the intention to become pregnant during the course of the study 5. Currently breastfeeding or before two spontaneous menstruations have occurred after cessation of breastfeeding prior to start of trial medication 6. Less than 6 weeks since last delivery/2nd trimester of abortion and before spontaneous menstruation has occurred following a delivery or 2nd trimester of abortion 7. Smoking if >= 35 years old at screening 8. Dyslipoproteinemia requiring active treatment with antilipidemic agent 9. Diabetes mellitus with vascular involvement or diabetes mellitus of more than 20 years duration 10. Any arterial hypertension (controlled and uncontrolled) defined by blood pressure values 11. Personal history of deep vein thrombosis or pulmonary embolism 12. Current prolonged immobilization or major surgery with prolonged immobilization planned in the next 12 months 13. Known inherited or acquired hypercoagulopathies or thrombogenic mutations 14. Current treatment with anticoagulants 15. Presence or history of atrial thromboembolism 16. Complicated valvular heart disease 17. History of pregnancy related cardiomyopathy or moderately or severely impaired cardiac function. 18. Systemic lupus erythematosus 19. Presence or history of migraine with aura at any age or migraine without aura if >35 years old 20. Within the past 6 months, has had undiagnosed (unexplained) abnormal vaginal bleeding or any abnormal bleeding that is expected to recur during the trial 21. In case of Chlamydial or Gonococcal infection at screening, when no treatment initiated at subject enrollment 22. Abnormal Pap test (written documentation of prior test at screening exam) based on provided criteria 23. Presence of an undiagnosed breast mass 24. Current symptomatic gallbladder disease 25. History of COC related cholestasis 26. Presence or history of severe hepatic disease as long as liver function values have not returned to normal 27. Presence or history of pancreatitis if associated with hypertriglyceridemia 28. Porphyria 29. Presence or history of hepatocellular adenoma or malignant liver tumors 30. Renal impairment 31. Hyperkaliemia or presence of conditions that predispose to hyperkaliemia such as renal impairment, hepatic impairment, adrenal insufficiency and women receiving daily, long-term treatment for chronic conditions or diseases with medications that may increase serum potassium concentration 32. History of organ transplantation within 5 years before screening or chronic disease potentially ecessitating organ transplantation during the anticipated
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the contraceptive efficacy of 15 mg E4/3 mg DRSP using the Pearl Index in subjects aged 18 to 35 years inclusive at the time of screening.;Primary end point(s): The number of on-treatment pregnancies as assessed by the Pearl Index in subjects aged 18 to 35 years, inclusive at the time of screening.;Timepoint(s) of evaluation of this end point: From day 1 of treatment until 2 days after the last intake of investigational product (whether active or inactive tablet) ; Secondary Objective: Efficacy: 1. To evaluate the contraceptive efficacy of 15 mg E4/3 mg DRSP using the method failure Pearl Index and the life table analysis in subjects aged 18 to 35 years inclusive at the time of screening. 2. To evaluate the contraceptive efficacy of 15 mg E4/3 mg DRSP using the Pearl Index, the method failure Pearl Index and life-table analysis in the overall study population. Other: 3. To evaluate cycle control and bleeding pattern associated with 15 mg E4/3 mg DRSP. 4. To evaluate general safety of 15 mg E4/3 mg DRSP. 5. To evaluate the impact of 15 mg E4/4 mg DRSP on physical, psychological and social functioning and well being. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: From day 1 of treatment until 2 days after the last intake of investigational product (whether active or inactive tablet); Secondary end point(s): Secondary efficacy endpoints: 1. The number of on-treatment pregnancies as assessed by the method failure Pearl Index and the cumulative pregnancy rate in subjects aged 18 to 35 years, inclusive at time of screening 2. The number of on-treatment pregnancies as assessed by the Pearl Index, the method failure Pearl Index and the cumulative pregnancy rate in the overall study population. Other secondary endpoints: 3. Cycle control and bleeding pattern evaluated based on vaginal bleeding information as recorded daily by the subjects in the diaries. 4. Safety data in the overall study population obtained from routine laboratory parameters, vital signs and physical, gynecological and breast examinations and by number, frequency, type and intensity of adverse events (AEs) and serious adverse events (SAEs). 5. Change from baseline to end of treatment in the different items of well-established questionnaires. | — |
Countries
Belgium, Czech Republic, Finland, Germany, Hungary, Norway, Poland, Russian Federation, Sweden
Contacts
Public ContactSophie Ledant
Estetra SPRL
Outcome results
None listed