NCT02817841

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 16 to 50 years.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,148

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Aug 2016

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 29, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

August 30, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 16, 2018

Completed
12 months until next milestone

Results Posted

Study results publicly available

November 6, 2019

Completed
Last Updated

February 10, 2020

Status Verified

October 1, 2019

Enrollment Period

2.1 years

First QC Date

June 27, 2016

Results QC Date

October 16, 2019

Last Update Submit

January 24, 2020

Conditions

Contraception

Keywords

EstetrolDrospirenonePrevention of pregnancyOral contraception

Outcome Measures

Primary Outcomes (1)

  • The Number of On-treatment Pregnancies (With + 7-day Window) Per 100 Woman-years of Exposure (Pearl Index) in Subjects Aged 16 to 35 Years, Inclusive, at the Time of Screening

    On-treatment pregnancies are pregnancies with an estimated date of conception within the in-treatment period i.e. Day 1 to 7 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, unless a conception occurred during a cycle. At-risk-cycle was defined as cycle in which no other methods of birth control (including condoms and emergency contraception) 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 (21)

  • The Number of On-treatment Pregnancies (With +7-day Window) as Assessed by the Method Failure Pearl Index in Subjects Aged 16 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 + 7-day Window) Per 100 Woman-years of Exposure (Pearl Index) in the Overall Study Population (16-50 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 (16-50 Years)

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

  • Rate of Pregnancy (Life-table Analysis) in Participants Aged 16 to 35 Years

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

  • Rate of Pregnancy (Life-table Analysis) in Participants Aged 16 to 50 Years

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

  • +16 more secondary outcomes

Study Arms (1)

15 mg E4/3 mg DRSP

EXPERIMENTAL

15 mg estetrol (E4)/3 mg drospirenone (DRSP) combined oral contraceptive

Drug: 15 mg E4/3 mg DRSP

Interventions

15 mg E4/3 mg DRSPDRUG

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

Age16 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Heterosexually active female at risk for pregnancy and requesting contraception.
  • Negative serum pregnancy test at subject screening.
  • 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.
  • 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 combined oral contraceptive (COC) related cholestasis.
  • Presence or history of severe hepatic disease.
  • Presence or history of pancreatitis if associated with hypertriglyceridemia.
  • Porphyria.
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Thomas Jefferson University Obstetrics and Gynecology

Philadelphia, Pennsylvania, 19107, United States

Location

Clinique de Santé des Femmes

Québec, Quebec, G1S 2L6, Canada

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: 37023457DERIVED

MeSH Terms

Interventions

Estetroldrospirenone

Intervention Hierarchy (Ancestors)

EstriolEstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, 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

August 30, 2016

Primary Completion

October 16, 2018

Study Completion

November 16, 2018

Last Updated

February 10, 2020

Results First Posted

November 6, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)US(1)