Cycle Control Assessment of a Combined Oral Contraceptive Containing Estetrol and a Progestin P1 or P2
FIESTA
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
2 other identifiers
interventional
396
1 country
10
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2010
Shorter than P25 for phase_2
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 13, 2010
CompletedFirst Posted
Study publicly available on registry
October 15, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedSeptember 14, 2012
September 1, 2012
1 year
October 13, 2010
September 13, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Recording of vaginal bleeding events (diary) as a measure of Cycle control
6 cycles of 28 days
Secondary Outcomes (6)
Measurement of pregnandiol glucuronide in urine as a measure of Ovulation inhibition
6 cycles of 28 days
Patient Reported Outcome questionnaire as a measure of Subject satisfaction
6 cycles of 28 days
Contacts patient-investigator to document Return of menstruation
for up to 1 year follow-up
Recording of adverse events, physical examination and laboratory parameters as a measure of Safety and Tolerability
up to 8 months
Measurement of SHBG in blood samples to assess the effect of treatment on SHBG
6 cycles of 28 days
- +1 more secondary outcomes
Study Arms (5)
estetrol dose 1 / P1
EXPERIMENTALestetrol dose 1 / P2
EXPERIMENTALestradiol valerate/dienogest pill
ACTIVE COMPARATORestetrol dose 2 / P1
EXPERIMENTALestetrol dose 2 / P2
EXPERIMENTALInterventions
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
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
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Estetralead
Study Sites (10)
Mehiläinen Helsinki
Helsinki, Finland
Väestöliitto Helsinki
Helsinki, Finland
YTHS Jyvaskyla
Jyväskylä, Finland
Laboratorio Simpanen
Kuopio, Finland
Terveystalo Kuopio
Kuopio, Finland
YTHS Kuopio
Kuopio, Finland
Väestöliitto Oulu
Oulu, Finland
Tampereen Lääkärikeskus Oy
Tampere, Finland
YTHS Tampere
Tampere, Finland
Väestöliitto Turku
Turku, Finland
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dan Apter, M.D.
Väestöliitto Helsinki
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 13, 2010
First Posted
October 15, 2010
Study Start
September 1, 2010
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
September 14, 2012
Record last verified: 2012-09