Last updated on June 2017

A Multicenter, Open-label, Single-Arm Study to Evaluate the Contraceptive Efficacy and Safety of a Combined Oral Contraceptive Containing 15 mg Estetrol and 3 mg Drospirenone

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Contraception
  • Gender: Female

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 IC.
  • 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 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/EU approved active ingredients, may be enrolled 2 months (60 days) after completing the preceding study.
  • Sponsor, CRO or Investigator's site personnel directly affiliated with this study.
  • Is judged by the Investigator to be unsuitable for any reason.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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