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

Contraception Clinical Trial

— FIESTA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01221831
• Other study ID #: ES-C02
• Secondary ID: 2010-019865-26
• Status: Completed
• Phase: Phase 2
• First received: October 13, 2010
• Last updated: September 13, 2012
• Start date: September 2010
• Est. completion date: September 2011

Study information

• Verified date: September 2012
• Source: Estetra
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical 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 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 396
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Contraception

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
Finland	Mehiläinen Helsinki	Helsinki
Finland	Väestöliitto Helsinki	Helsinki
Finland	YTHS Jyvaskyla	Jyvaskyla
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

Sponsors (1)

Lead Sponsor	Collaborator
Estetra

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recording of vaginal bleeding events (diary) as a measure of Cycle control		6 cycles of 28 days	No
Secondary	Measurement of pregnandiol glucuronide in urine as a measure of Ovulation inhibition		6 cycles of 28 days	No
Secondary	Patient Reported Outcome questionnaire as a measure of Subject satisfaction		6 cycles of 28 days	Yes
Secondary	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)	for up to 1 year follow-up	Yes
Secondary	Recording of adverse events, physical examination and laboratory parameters as a measure of Safety and Tolerability		up to 8 months	Yes
Secondary	Measurement of SHBG in blood samples to assess the effect of treatment on SHBG		6 cycles of 28 days	Yes
Secondary	Reporting of in-treatment pregnancies as a measure of pregnancy rate		6 cycles of 28 days	No