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

NCT ID: NCT02957630

Last Updated: 2018-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2017-10-09

Brief 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.

Conditions

Contraception; Liver Metabolism; Hemostasis Parameter

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

15 mg E4/3 mg DRSP

15 mg estetrol/3 mg drospirenone combined oral contraceptive

Group Type: EXPERIMENTAL

15 mg E4/3 mg DRSP

Intervention Type: DRUG

15 mg E4 combined with 3 mg DRSP administered in a 24/4-day regimen (i.e. 24 days of pink active tablets followed by 4 days of white placebo tablets). One tablet per day orally for 6 treatment cycles.

30 mcg EE/150 mcg LNG

30 mcg ethinylestradiol/150 mcg levonorgestrel combined oral contraceptive

Group Type: ACTIVE_COMPARATOR

30 mcg EE/150 mcg LNG

Intervention Type: DRUG

30 mcg EE combined with 150 mcg LNG administered in a 21/7-day regimen (i.e. 21 days of yellow active tablets followed by 7 days of white placebo tablets). One tablet per day orally for 6 treatment cycles.

20 mcg EE/3 mg DRSP

20 mcg ethinylestradiol/3 mg drospirenone combined oral contraceptive

Group Type: ACTIVE_COMPARATOR

20 mcg EE/3 mg DRSP

Intervention Type: DRUG

20 mcg EE combined with 3 mg DRSP administered in a 24/4-day regimen (i.e. 24 days of pink active tablets followed by 4 days of white placebo tablets). One tablet per day orally for 6 treatment cycles.

Interventions

15 mg E4/3 mg DRSP

15 mg E4 combined with 3 mg DRSP administered in a 24/4-day regimen (i.e. 24 days of pink active tablets followed by 4 days of white placebo tablets). One tablet per day orally for 6 treatment cycles.

Intervention Type: DRUG

30 mcg EE/150 mcg LNG

30 mcg EE combined with 150 mcg LNG administered in a 21/7-day regimen (i.e. 21 days of yellow active tablets followed by 7 days of white placebo tablets). One tablet per day orally for 6 treatment cycles.

Intervention Type: DRUG

20 mcg EE/3 mg DRSP

20 mcg EE combined with 3 mg DRSP administered in a 24/4-day regimen (i.e. 24 days of pink active tablets followed by 4 days of white placebo tablets). One tablet per day orally for 6 treatment cycles.

Intervention Type: DRUG

Other Intervention Names

15 mg estetrol and 3 mg drospirenone; 30 mcg ethinylestradiol and 150 mcg levonorgestrel; 20 mcg ethinylestradiol and 3 mg drospirenone

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Estetra

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christine Klipping

Role: PRINCIPAL_INVESTIGATOR

Dinox BV

Locations

Dinox BV

Groningen, , Netherlands

Countries

Netherlands

Other Identifiers

2016-001316-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MIT-Es0001-C201

Identifier Type: -

Identifier Source: org_study_id