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

  • STATUS
    Recruiting
Updated on 25 March 2021

Summary

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

Description

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.

Details
Clinical Study IdentifierTX150144
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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