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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Estetra S.A.
ClinicalTrials.gov Identifier:
NCT01221831
First received: October 13, 2010
Last updated: September 13, 2012
Last verified: September 2012
  Purpose

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

Condition Intervention Phase
Contraception
Drug: estetrol, P 1 and placebo tablets
Drug: estetrol, P2 and placebo tablets
Drug: Estradiol valerate, dienogest and placebo tablets
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Estetra S.A.:

Primary Outcome Measures:
  • Recording of vaginal bleeding events (diary) as a measure of Cycle control [ Time Frame: 6 cycles of 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measurement of pregnandiol glucuronide in urine as a measure of Ovulation inhibition [ Time Frame: 6 cycles of 28 days ] [ Designated as safety issue: No ]
  • Patient Reported Outcome questionnaire as a measure of Subject satisfaction [ Time Frame: 6 cycles of 28 days ] [ Designated as safety issue: Yes ]
  • Contacts patient-investigator to document Return of menstruation [ Time Frame: for up to 1 year follow-up ] [ Designated as safety issue: Yes ]
    (only in case the patient does not start up a new hormonal contraceptive method or in case of pregnancy wish)

  • Recording of adverse events, physical examination and laboratory parameters as a measure of Safety and Tolerability [ Time Frame: up to 8 months ] [ Designated as safety issue: Yes ]
  • Measurement of SHBG in blood samples to assess the effect of treatment on SHBG [ Time Frame: 6 cycles of 28 days ] [ Designated as safety issue: Yes ]
  • Reporting of in-treatment pregnancies as a measure of pregnancy rate [ Time Frame: 6 cycles of 28 days ] [ Designated as safety issue: No ]

Enrollment: 396
Study Start Date: September 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01221831

Locations
Finland
Mehiläinen Helsinki
Helsinki, Finland
Väestöliitto Helsinki
Helsinki, Finland
YTHS Jyvaskyla
Jyvaskyla, Finland
Terveystalo Kuopio
Kuopio, Finland
YTHS Kuopio
Kuopio, Finland
Laboratorio Simpanen
Kuopio, Finland
Väestöliitto Oulu
Oulu, Finland
Tampereen Lääkärikeskus Oy
Tampere, Finland
YTHS Tampere
Tampere, Finland
Väestöliitto Turku
Turku, Finland
Sponsors and Collaborators
Estetra S.A.
Investigators
Principal Investigator: Dan Apter, M.D. Väestöliitto Helsinki
  More Information

No publications provided

Responsible Party: Estetra S.A.
ClinicalTrials.gov Identifier: NCT01221831     History of Changes
Other Study ID Numbers: ES-C02, 2010-019865-26
Study First Received: October 13, 2010
Last Updated: September 13, 2012
Health Authority: Finland: Finnish Medicines Agency

Additional relevant MeSH terms:
Contraceptive Agents
Contraceptives, Oral
Contraceptives, Oral, Combined
Dienogest
Estradiol
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estradiol valerate
Polyestradiol phosphate
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Contraceptive Agents, Female
Contraceptive Agents, Male
Estrogens
Hormone Antagonists
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014