ContraceptionPhase 2FIESTANCT01221831
Cycle Control Assessment of a Combined Oral Contraceptive Containing Estetrol and a Progestin P1 or P2
A Phase 2 study of Contraception, run by Estetra at 10 sites in Finland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 396 participants
- Where
- 10 sitesFinland
- Study dates
- Sep 2010to Sep 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Finland10 sites
Mehiläinen Helsinki
Helsinki
Väestöliitto Helsinki
Helsinki
YTHS Jyvaskyla
Jyväskylä
Laboratorio Simpanen
Kuopio
Terveystalo Kuopio
Kuopio
YTHS Kuopio
Kuopio
Väestöliitto Oulu
Oulu
Tampereen Lääkärikeskus Oy
Tampere
YTHS Tampere
Tampere
Väestöliitto Turku
Turku
About this study
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
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
- Conditions
- Contraception
- Being tested
- estetrol, P 1 and placebo tablets, estetrol, P2 and placebo tablets, Estradiol valerate, dienogest and placebo tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
estetrol, P 1 and placebo tabletsDrug
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
estetrol, P2 and placebo tabletsDrug
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
Estradiol valerate, dienogest and placebo tabletsDrug
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
| Study group | Role | What they receive |
|---|---|---|
| estetrol dose 1 / P1 | Experimental | Not described Receives: Drug: estetrol, P 1 and placebo tablets |
| estetrol dose 1 / P2 | Experimental | Not described Receives: Drug: estetrol, P2 and placebo tablets |
| estradiol valerate/dienogest pill | Active comparator | Not described Receives: Drug: Estradiol valerate, dienogest and placebo tablets |
| estetrol dose 2 / P1 | Experimental | Not described Receives: Drug: estetrol, P 1 and placebo tablets |
| estetrol dose 2 / P2 | Experimental | Not described Receives: Drug: estetrol, P2 and placebo tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recording of vaginal bleeding events (diary) as a measure of Cycle control
Measured: 6 cycles of 28 days
Secondary outcomes (6)
Measurement of pregnandiol glucuronide in urine as a measure of Ovulation inhibition
Measured: 6 cycles of 28 days
Patient Reported Outcome questionnaire as a measure of Subject satisfaction
Measured: 6 cycles of 28 days
Contacts patient-investigator to document Return of menstruation
(only in case the patient does not start up a new hormonal contraceptive method or in case of pregnancy wish)
Measured: for up to 1 year follow-up
Recording of adverse events, physical examination and laboratory parameters as a measure of Safety and Tolerability
Measured: up to 8 months
Measurement of SHBG in blood samples to assess the effect of treatment on SHBG
Measured: 6 cycles of 28 days
Reporting of in-treatment pregnancies as a measure of pregnancy rate
Measured: 6 cycles of 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 396 participants (actual)
Sponsor and investigators
- Lead sponsor
- Estetra
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dan Apter, M.D., Principal investigator, Väestöliitto Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01221831
- Sponsor's protocol ID
- ES-C02
- Other IDs
- 2010-019865-26
- Acronym
- FIESTA
- Status last verified
- Sep 2012
- First submitted
- 13 Oct 2010
- Last updated
- 14 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01221831
- Acronym / sponsor ID
- FIESTA / ES-C02
- Conditions
- Contraception
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 396 participants (actual)
- Lead sponsor
- EstetraIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 15 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| estetrol dose 1 / P1 | Experimental | Drug: estetrol, P 1 and placebo tablets |
| estetrol dose 1 / P2 | Experimental | Drug: estetrol, P2 and placebo tablets |
| estradiol valerate/dienogest pill | Active comparator | Drug: Estradiol valerate, dienogest and placebo tablets |
| estetrol dose 2 / P1 | Experimental | Drug: estetrol, P 1 and placebo tablets |
| estetrol dose 2 / P2 | Experimental | Drug: estetrol, P2 and placebo tablets |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| estetrol, P 1 and placebo tablets6 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 dose 1 / P1, estetrol dose 2 / P1 |
| estetrol, P2 and placebo tablets6 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 | estetrol dose 1 / P2, estetrol dose 2 / P2 |
| Estradiol valerate, dienogest and placebo tablets6 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 | Drug | estradiol valerate/dienogest pill |
Primary outcome
Recording of vaginal bleeding events (diary) as a measure of Cycle control
Time frame: 6 cycles of 28 days
6 secondary outcomes
Measurement of pregnandiol glucuronide in urine as a measure of Ovulation inhibition
Time frame: 6 cycles of 28 days
Patient Reported Outcome questionnaire as a measure of Subject satisfaction
Time frame: 6 cycles of 28 days
Contacts patient-investigator to document Return of menstruation
Time frame: 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
Measurement of SHBG in blood samples to assess the effect of treatment on SHBG
Time frame: 6 cycles of 28 days
Reporting of in-treatment pregnancies as a measure of pregnancy rate
Time frame: 6 cycles of 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dan Apter, M.D. principal investigator
Väestöliitto Helsinki
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Contraception, run by Estetra at 10 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recording of vaginal bleeding events (diary) as a measure of Cycle control (time frame: 6 cycles of 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2012; AzTrials last refreshed its copy on 8 Nov 2026.