E4 FREEDOM (Female Response Concerning Efficacy and Safety of Estetrol/Drospirenone as Oral Contraceptive in a Multicentric Study) - EU/Russia Study

NCT ID: NCT02817828

Last Updated: 2019-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1577 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2018-04-26

Brief Summary

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 18 to 50 years.

Conditions

Contraception

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

15 mg E4/3 mg DRSP

15 mg E4/3 mg DRSP tablet

Group Type: EXPERIMENTAL

15 mg E4/3 mg DRSP

Intervention Type: DRUG

15 mg estetrol and 3 mg drospirenone tablets administered once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days.

Interventions

15 mg E4/3 mg DRSP

15 mg estetrol and 3 mg drospirenone tablets administered once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days.

Intervention Type: DRUG

Other Intervention Names

15 mg estetrol and 3 mg drospirenone

Eligibility Criteria

Inclusion Criteria

• Heterosexually active female at risk for pregnancy and requesting contraception.
• Negative serum pregnancy test at subject enrollment.
• 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 informed consent (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.
• Use of drugs potentially triggering interactions with COCs.
• History of alcohol or drug abuse (including laxatives) within 12 months prior to screening.
• 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.

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

Sponsors

PRA Health Sciences

INDUSTRY

Sponsor Role: collaborator

Estetra

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Estetra

Role: STUDY_DIRECTOR

Estetra

Locations

Hopital Saint-Pierre

Brussels, , Belgium

Countries

Belgium

References

Creinin MD, Jensen JT, Chen MJ, Black A, Costescu D, Foidart JM. Combined Oral Contraceptive Adherence and Pregnancy Rates. Obstet Gynecol. 2023 May 1;141(5):989-994. doi: 10.1097/AOG.0000000000005155. Epub 2023 Apr 5.

Reference Type: DERIVED

PMID: 37023457 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

MIT-Es0001-C301

Identifier Type: -

Identifier Source: org_study_id