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

Estetra

Status and phase: Completed; Phase 2; Phase 1

Conditions: Hemostasis Parameter; Liver Metabolism; Contraception

Treatments: Drug: 20 mcg EE/3 mg DRSP; Drug: 15 mg E4/3 mg DRSP; Drug: 30 mcg EE/150 mcg LNG

Study type: Interventional

Funder types: Industry

Identifiers

NCT02957630

2016-001316-37 (EudraCT Number)

MIT-Es0001-C201

Details and patient eligibility

About

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.

Enrollment: 101 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

101 participants in 3 patient groups

15 mg E4/3 mg DRSP

Experimental group

Description:

15 mg estetrol/3 mg drospirenone combined oral contraceptive

Treatment:

Drug: 15 mg E4/3 mg DRSP

30 mcg EE/150 mcg LNG

Active Comparator group

Description:

30 mcg ethinylestradiol/150 mcg levonorgestrel combined oral contraceptive

Treatment:

Drug: 30 mcg EE/150 mcg LNG

20 mcg EE/3 mg DRSP

Active Comparator group

Description:

20 mcg ethinylestradiol/3 mg drospirenone combined oral contraceptive

Treatment:

Drug: 20 mcg EE/3 mg DRSP