E4 FREEDOM (Female Response Concerning Efficacy and Safety of Estetrol/Drospirenone as Oral Contraceptive in a Multicentric Study) - United States/Canada Study

Estetra

Status and phase

Completed

Phase 3

Conditions

Contraception

Treatments

Drug: 15 mg E4/3 mg DRSP

Study type

Interventional

Funder types

Industry

Identifiers

NCT02817841

MIT-Es0001-C302

Details and patient eligibility

About

The objectives of this study are to evaluate the contraceptive efficacy, vaginal bleeding pattern (cycle control), and the general safety and acceptability of the 15 mg estetrol (E4)/3 mg drospirenone (DRSP) combination in healthy women aged 16 to 50 years.

Enrollment

2,148 patients

Sex

Female

Ages

16 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Heterosexually active female at risk for pregnancy and requesting contraception.
Negative serum pregnancy test at subject screening.
Willing to use the investigational product as the primary method of contraception for 13 consecutive cycles.
Good physical and mental health on the basis of medical, surgical and gynecological history, physical examination, gynecological examination, clinical laboratory, and vital signs.
Body mass index (BMI) below or equal to (≤) 35.0 kg/m2.
Able to fulfill the requirements of the protocol and have indicated a willingness to participate in the study by providing written informed consent.
Willing and able to complete the diaries and questionnaires.

Exclusion criteria

Known hypersensitivity to any of the investigational product ingredients.
Smoking if ≥ 35 years old, at screening.
Any condition associated with decrease fertility.
Dyslipoproteinemia requiring active treatment with antilipidemic agent.
Diabetes mellitus with vascular involvement (nephropathy, retinopathy, neuropathy, other) or diabetes mellitus of more than 20-year duration.
Arterial hypertension.
Any condition associated with an increased risk of venous thromboembolism and/or arterial thromboembolism.
Any condition associated with abnormal uterine/vaginal bleeding.
Abnormal Pap test based on current international recommendations.
Presence of an undiagnosed breast mass.
Current symptomatic gallbladder disease.
History of combined oral contraceptive (COC) related cholestasis.
Presence or history of severe hepatic disease.
Presence or history of pancreatitis if associated with hypertriglyceridemia.
Porphyria.
Presence or history of hepatocellular adenoma or malignant liver tumors.
Renal impairment.
Hyperkaliemia or presence of conditions that predispose to hyperkaliemia.
Presence or history of hormone-related malignancy.
History of non-hormone-related malignancy within 5 years before screening. Subjects with a non-melanoma skin cancer are allowed in the study.
History of alcohol or drug abuse (including laxatives) within 12 months prior to screening.
Use of drugs potentially triggering interactions with COCs.
Any condition that could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the investigational product.
Uncontrolled thyroid disorders.
Participation in another investigational drug clinical study within 1 month (30 days) or have received an investigational drug within the last 3 months (90 days) prior to study entry. Subjects who participated in an oral contraceptive clinical study, using FDA/European (EU) approved active ingredients, may be enrolled 2 months (60 days) after completing the preceding study.
Sponsor, Contract Research Organization (CRO) or Investigator's site personnel directly affiliated with this study.
Is judged by the Investigator to be unsuitable for any reason.