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

October 13, 2010
September 13, 2012
September 2010
September 2011   (final data collection date for primary outcome measure)
Recording of vaginal bleeding events (diary) as a measure of Cycle control [ Time Frame: 6 cycles of 28 days ] [ Designated as safety issue: No ]
Recording of vaginal bleeding events (diary) as a measure of Cycle control [ Time Frame: 4 cycles of 28 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01221831 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Measurement of pregnandiol glucuronide in urine as a measure of Ovulation inhibition [ Time Frame: 4 cycles of 28 days ] [ Designated as safety issue: No ]
  • Patient Reported Outcome questionnaire as a measure of Subject satisfaction [ Time Frame: 4 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 6 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Cycle Control Assessment of a Combined Oral Contraceptive Containing Estetrol and a Progestin P1 or P2
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
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Contraception
  • 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
  • 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
  • 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 1 / P1
    Intervention: Drug: estetrol, P 1 and placebo tablets
  • Experimental: estetrol dose 1 / P2
    Intervention: Drug: estetrol, P2 and placebo tablets
  • Active Comparator: estradiol valerate/dienogest pill
    Intervention: Drug: Estradiol valerate, dienogest and placebo tablets
  • Experimental: estetrol dose 2 / P1
    Intervention: Drug: estetrol, P 1 and placebo tablets
  • Experimental: estetrol dose 2 / P2
    Intervention: Drug: estetrol, P2 and placebo tablets
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
396
September 2011
September 2011   (final data collection date for primary outcome measure)

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
Female
18 Years to 35 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT01221831
ES-C02, 2010-019865-26
No
Estetra S.A.
Estetra S.A.
Not Provided
Principal Investigator: Dan Apter, M.D. Väestöliitto Helsinki
Estetra S.A.
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP