A clinical study to investigate the efficacy and safety of a new combination oral contraceptive tablet. All participants will receive the same combination oral contraceptive.

Phase 1

• Conditions: Contraception; MedDRA version: 20.0 Level: PT Classification code 10030970 Term: Oral contraception System Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]

• Registration Number: EUCTR2015-003150-40-CZ
• Lead Sponsor: Estetra SPR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-01-08
• Study Completion: 2018-10-17
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 1553

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

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

Study & Design

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