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

• Status: Completed
• Trial end date: 2018-11-16
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Estetra
• Collaborator: PRA Health Sciences
• Treatments: Contraceptive Agents; Contraceptives, Oral; Contraceptives, Oral, Combined; Drospirenone

Criteria

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.