Cycle Control Assessment of a Combined Oral Contraceptive Containing Estetrol and a Progestin P1 or P2 (FIESTA)
This study has been completed.
Sponsor:
Estetra S.A.
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
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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:
Drug Information available for:
Estradiol
Estradiol cypionate
Estradiol valerate
Estradiol acetate
Estradiol hemihydrate
Dienogest
U.S. FDA Resources
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:
|
| Experimental: estetrol dose 1 / P2 |
Drug: estetrol, P2 and placebo tablets
6 treatment cycles each consisting of 28 days of oral administration as follows:
|
| 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:
|
| 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:
|
| Experimental: estetrol dose 2 / P2 |
Drug: estetrol, P2 and placebo tablets
6 treatment cycles each consisting of 28 days of oral administration as follows:
|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01221831
Locations
| Finland | |
| Väestöliitto Helsinki | |
| Helsinki, Finland | |
| Mehiläinen Helsinki | |
| Helsinki, Finland | |
| YTHS Jyvaskyla | |
| Jyvaskyla, Finland | |
| YTHS Kuopio | |
| Kuopio, Finland | |
| Terveystalo Kuopio | |
| Kuopio, Finland | |
| Laboratorio Simpanen | |
| Kuopio, Finland | |
| Väestöliitto Oulu | |
| Oulu, Finland | |
| YTHS Tampere | |
| Tampere, Finland | |
| Tampereen Lääkärikeskus Oy | |
| 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 Estradiol valerate Estradiol 3-benzoate Estradiol 17 beta-cypionate Dienogest Contraceptives, Oral Contraceptives, Oral, Combined Estradiol Polyestradiol phosphate Reproductive Control Agents Physiological Effects of Drugs |
Pharmacologic Actions Therapeutic Uses Contraceptive Agents, Female Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Contraceptive Agents, Male |
ClinicalTrials.gov processed this record on May 22, 2013