Cycle Control Assessment of a Combined Oral Contraceptive Containing Estetrol and a Progestin P1 or P2 (FIESTA)

September 13, 2012 updated by: Estetra

A Randomised Open-label Multi-centre Comparative Study to Evaluate Cycle Control of 2 Dosages of Estetrol Combined With Either P1 or P2, Compared to a Combined Oral Contraceptive Containing E2V and DNG

This is an open-label, multi-centre, comparative study in young, healthy, female volunteers of reproductive age.

Primary objective:

- To investigate the effect of 2 dosages of estetrol combined with P1 or P2, on vaginal bleeding patterns (cycle control), in comparison with a combined oral contraceptive containing estradiol valerate and dienogest

Secondary objectives:

  • To investigate ovulation inhibition
  • To investigate the effect on SHBG
  • To assess pregnancy rate
  • To evaluate subject satisfaction, dysmenorrhoea, acne, and body weight
  • To investigate return of menstruation after treatment
  • To evaluate general safety and acceptability

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
396

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland
        • Mehiläinen Helsinki
      • Helsinki, Finland
        • Väestöliitto Helsinki
      • Jyvaskyla, Finland
        • YTHS Jyvaskyla
      • Kuopio, Finland
        • Laboratorio Simpanen
      • Kuopio, Finland
        • Terveystalo Kuopio
      • Kuopio, Finland
        • YTHS Kuopio
      • Oulu, Finland
        • Väestöliitto Oulu
      • Tampere, Finland
        • Tampereen Lääkärikeskus Oy
      • Tampere, Finland
        • YTHS Tampere
      • Turku, Finland
        • Väestöliitto Turku

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women willing to use a Combined Oral Contraceptive for 6 subsequent cycles
  • Good physical and mental health
  • Regular menstrual cycle (24-35 days) prior to screening
  • Body mass index between (≥) 18 and (≤) 30 kg/m2

Exclusion Criteria:

  • Previous use of any hormonal contraceptive method during the last 3 months prior to randomisation (only applicable for women who are not using a hormonal contraceptive method at the time of screening)
  • Previous use of progestogen-only contraceptive methods during the last 3 months or during the last 6 months for depot progestogen preparations or an injectable hormonal method of contraception
  • Use of phytoestrogens
  • No spontaneous menstruation has occurred following a delivery or abortion
  • Breastfeeding or within 2 months after stopping breastfeeding prior to the start of study medication and no spontaneous return of menstruation
  • Status post-partum or post-abortion within a period of 2 months before screening
  • Pregnancy during accurate hormonal contraceptive use in the past
  • Intention to become pregnant during the study
  • An abnormal cervical smear within one year before study start
  • Untreated Chlamydia infection
  • Known or suspected breast cancer or a history of breast cancer
  • A history of (within 12 months) alcohol or drug abuse
  • Any clinically relevant abnormality
  • Contraindications for the contraceptive steroids used in the clinical trial
  • Use of antihypertensive drugs or use of medications interacting with the contraceptive steroids used in the clinical trial
  • Administration of any other investigational drug within 2 months prior to screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: estetrol dose 1 / P1
Drug: estetrol, P 1 and placebo tablets

6 treatment cycles each consisting of 28 days of oral administration as follows:

  • Days 1-24: one estetrol tablet and one P1 tablet per day
  • Days 25-28: two placebo tablets per day
EXPERIMENTAL: estetrol dose 1 / P2
Drug: estetrol, P2 and placebo tablets

6 treatment cycles each consisting of 28 days of oral administration as follows:

  • Days 1-24: one estetrol tablet and one P2 tablet per day
  • Days 25-28: two placebo tablets per day
ACTIVE_COMPARATOR: estradiol valerate/dienogest pill
Drug: Estradiol valerate, dienogest and placebo tablets

6 treatment cycles each consisting of 28 days of oral administration as follows:

  • Days 1-26: one tablet of Estradiol valerate/dienogest per day
  • Days 26-28: one placebo tablet per day
EXPERIMENTAL: estetrol dose 2 / P1
Drug: estetrol, P 1 and placebo tablets

6 treatment cycles each consisting of 28 days of oral administration as follows:

  • Days 1-24: one estetrol tablet and one P1 tablet per day
  • Days 25-28: two placebo tablets per day
EXPERIMENTAL: estetrol dose 2 / P2
Drug: estetrol, P2 and placebo tablets

6 treatment cycles each consisting of 28 days of oral administration as follows:

  • Days 1-24: one estetrol tablet and one P2 tablet per day
  • Days 25-28: two placebo tablets per day

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Recording of vaginal bleeding events (diary) as a measure of Cycle control
Time Frame: 6 cycles of 28 days
6 cycles of 28 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Measurement of pregnandiol glucuronide in urine as a measure of Ovulation inhibition
Time Frame: 6 cycles of 28 days
6 cycles of 28 days
Patient Reported Outcome questionnaire as a measure of Subject satisfaction
Time Frame: 6 cycles of 28 days
6 cycles of 28 days
Contacts patient-investigator to document Return of menstruation
Time Frame: for up to 1 year follow-up
(only in case the patient does not start up a new hormonal contraceptive method or in case of pregnancy wish)
for up to 1 year follow-up
Recording of adverse events, physical examination and laboratory parameters as a measure of Safety and Tolerability
Time Frame: up to 8 months
up to 8 months
Measurement of SHBG in blood samples to assess the effect of treatment on SHBG
Time Frame: 6 cycles of 28 days
6 cycles of 28 days
Reporting of in-treatment pregnancies as a measure of pregnancy rate
Time Frame: 6 cycles of 28 days
6 cycles of 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Estetra

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dan Apter, M.D., Väestöliitto Helsinki

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2010

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2011

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 13, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2010

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 15, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 14, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ES-C02
  • 2010-019865-26 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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