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

NCT02817828 | Completed Phase 3 Results

• 1 other identifier: MIT-Es0001-C301
• Study Type: interventional
• Target: 1,577
• Locations: 1 country
• Sites: 1

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

Keywords

Estetrol

Outcome Measures

Primary Outcomes (1)

• The Number of On-treatment Pregnancies (With + 2-day Window) Per 100 Woman-years of Exposure (Pearl Index) in Subjects Aged 18 to 35 Years, Inclusive, at the Time of Screening

  On-treatment pregnancies are defined as pregnancies with an estimated date of conception within the in-treatment period i.e. Day 1 to 2 days after the last intake of investigational product (whether active or inactive tablet). The Pearl Index, defined as the number of pregnancies per 100 women-years of treatment was calculated as: Pearl Index = (1300\*number of on-treatment pregnancies)/number of women 28-day equivalent cycles of treatment.Only at-risk cycles were included in the denominator of the Pearl Index calculation. At-risk-cycles were defined as cycles in which no other methods of birth control (including condoms) were used by the subject as confirmed in the subject diary and during which the subject confirmed that sexual intercourse had occurred.

  Up to 12 months (13 cycles with 1 cycle = 28 days)

Secondary Outcomes (16)

• The Number of On-treatment Pregnancies (With 2-day Window) as Assessed by the Method Failure Pearl Index in Subjects Aged 18 to 35 Years, Inclusive, at the Time of Screening

  Up to 12 months (13 cycles with 1 cycle = 28 days)

• The Number of On-treatment Pregnancies (With + 2-day Window) Per 100 Woman-years of Exposure (Pearl Index) in the Overall Study Population (18-50 Years)

  Up to 12 months (13 cycles with 1 cycle = 28 days)

• The Number of On-Treatment Pregnancies as Assessed by the Method Failure Pearl Index in the Overall Study Population (18-50 Years)

  Up to 12 months (13 cycles with 1 cycle = 28 days)

• Number of Subjects With Unscheduled Bleeding/Spotting

  Up to 11 months (12 cycles with 1 cycle = 28 days)

• Number of Unscheduled Bleeding Days Per Cycle

  Up to 11 months (12 cycles with 1 cycle = 28 days)

Study Arms (1)

15 mg E4/3 mg DRSP

EXPERIMENTAL

15 mg E4/3 mg DRSP tablet

Drug: 15 mg E4/3 mg DRSP

Interventions

15 mg E4/3 mg DRSP 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.

Also known as: 15 mg estetrol and 3 mg drospirenone

15 mg E4/3 mg DRSP

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Estetra: lead
• PRA Health Sciences: collaborator

Study Sites (1)

Hopital Saint-Pierre

Brussels, 1000, Belgium

Location

Related Publications (1)

• 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.

  PMID: 37023457 DERIVED

MeSH Terms

Interventions

Estetrol; drospirenone

Intervention Hierarchy (Ancestors)

Estriol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Mithra Pharmaceuticals SA Pharma Department
• Organization: Estetra SPRL

clinical.trials@mithra.com

+3243492822

Study Officials

• Estetra

  Estetra

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2016
• First Posted: June 29, 2016
• Study Start: June 1, 2016
• Primary Completion: April 26, 2018
• Study Completion: April 26, 2018
• Last Updated: October 4, 2019
• Results First Posted: October 4, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)