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NCT Number: NCT01221831

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

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

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Key information

Conditions

Contraception

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Mehiläinen Helsinki, Helsinki, Finland

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

estetrol, P 1 and placebo tablets

Drug

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

Drug

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

Drug

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

Primary outcomes

  1. Recording of vaginal bleeding events (diary) as a measure of Cycle control

    Time frame: 6 cycles of 28 days

Secondary outcomes

  1. Measurement of pregnandiol glucuronide in urine as a measure of Ovulation inhibition

    Time frame: 6 cycles of 28 days

  2. Patient Reported Outcome questionnaire as a measure of Subject satisfaction

    Time frame: 6 cycles of 28 days

  3. Contacts patient-investigator to document Return of menstruation

    Time frame: for up to 1 year follow-up

    (only in case the patient does not start up a new hormonal contraceptive method or in case of pregnancy wish)

  4. Recording of adverse events, physical examination and laboratory parameters as a measure of Safety and Tolerability

    Time frame: up to 8 months

  5. Measurement of SHBG in blood samples to assess the effect of treatment on SHBG

    Time frame: 6 cycles of 28 days

  6. Reporting of in-treatment pregnancies as a measure of pregnancy rate

    Time frame: 6 cycles of 28 days

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Sponsors and collaborators

Lead sponsor

Estetra

Industry

Registry information

Official study 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

Acronym: FIESTA

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 15, 2010
Registry last updated
Sep 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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