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: 19.0Level: PTClassification code 10030970Term: Oral contraceptionSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-15
• Last Update Posted: 28 May 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 1550

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 (=) 35.0 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 he 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 necessitating organ transplantation during
the anticipated course of the study
33. Presence or history of hormone-related malignancy
34. History of non-hormone-related malignancy within 5 years before
screening. Subjects with a non-melanoma skin cancer are allowed in the
study
35. Current regular use or regular use within 1 month prior to subject enrollment of drugs potentially triggering interactions with COCs
36. Use of an injectable hormonal method of contraception within 10
months prior to screening of an injecti

Study & Design

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