"E4/DRSP Endocrine Function, Metabolic Control and Hemostasis Study"

• Status: Completed
• Trial end date: 2017-10-09
• Target enrollment: 0
• Participant gender: Female

Summary

The proposed study will provide an assessment of the effect of this combination on endocrine function, metabolic control and hemostasis during 6 treatment cycles. This will be compared to the effects of two reference COCs.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Estetra
• Treatments: Contraceptive Agents; Contraceptives, Oral; Contraceptives, Oral, Combined; Drospirenone; Ethinyl Estradiol; Hemostatics; Levonorgestrel

Criteria

Inclusion Criteria:

• Healthy adult woman

• Negative pregnancy test at subject screening and randomization

• Aged 18-50 years (inclusive) at the time of signing the ICF

• Good physical and mental health on the basis of medical, surgical and gynecological history, physical examination, gynecological examination, clinical laboratory, ECG, echocardiography and vital signs

• BMI from 18.0 to 30.0 kg/m², inclusive, at time of screening visit

• Able to fulfil the requirements of the protocol and have indicated a willingness to participate in the study by providing written informed consent

Exclusion Criteria:

• Known hypersensitivity to any of the investigational product ingredients

• Smoking if > 35 years old

• Dyslipoproteinemia or use of antilipidemic agent

• Known diabetes mellitus

• Current use of antidiabetic drugs, including insulin

• Arterial hypertension

• Any condition associated with an increased risk of venous thromboembolism and/or arterial thromboembolism.

• Any condition associated with abnormal uterine/vaginal bleeding.

• Presence of an undiagnosed breast mass

• Current symptomatic gallbladder disease

• History of pregnancy- or COC-related cholestasis

• Presence or history of severe hepatic disease

• Presence or history of pancreatitis if associated with hypertriglyceridemia

• Porphyria

• Presence or history of benign liver tumors (focal nodular hyperplasia and hepatocellular adenoma)

• Presence of renal impairment (glomerular filtration rate [GFR] <60 mL/min/1.73m²)

• Hyperkalemia or presence of conditions that predispose to hyperkalemia

• 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

• Use of drugs potentially triggering interactions with COCs

• History of alcohol or drug abuse within 12 months prior to screening

• Presence or history of 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 randomization. Subjects who participated in an oral contraceptive clinical study using Food and Drug Administration (FDA)/European Union (EU) approved active ingredients, may be randomized 2 months (60 days) after completing the preceding study

• Sponsor, contract research organization (CRO) or Principal Investigator's (PI's) site personnel directly affiliated with this study

• Is judged by the PI to be unsuitable for any reason