Clinical trial NCT01221831: Cycle Control Assessment of a Combined Oral Contraceptive Containing Estetrol and a Progestin P1 or P2
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Contraception
Lead sponsor: Estetra
Sponsor class: INDUSTRY
First posted: 2010-10-15
Enrollment: 396
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Recording of vaginal bleeding events (diary) as a measure of Cycle control
timeFrame: 6 cycles of 28 days
Secondary outcomes:
measure: Measurement of pregnandiol glucuronide in urine as a measure of Ovulation inhibition
timeFrame: 6 cycles of 28 days
measure: Patient Reported Outcome questionnaire as a measure of Subject satisfaction
timeFrame: 6 cycles of 28 days
measure: Contacts patient-investigator to document Return of menstruation
timeFrame: for up to 1 year follow-up
measure: Recording of adverse events, physical examination and laboratory parameters as a measure of Safety and Tolerability
timeFrame: up to 8 months
measure: Measurement of SHBG in blood samples to assess the effect of treatment on SHBG
timeFrame: 6 cycles of 28 days
measure: Reporting of in-treatment pregnancies as a measure of pregnancy rate
timeFrame: 6 cycles of 28 days
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Mehiläinen Helsinki
city: Helsinki
country: Finland
facility: Väestöliitto Helsinki
city: Jyvaskyla
country: Finland
facility: YTHS Jyvaskyla
city: Kuopio
country: Finland
facility: Laboratorio Simpanen
city: Kuopio
country: Finland
facility: Terveystalo Kuopio
city: Kuopio
country: Finland
facility: YTHS Kuopio
city: Oulu
country: Finland
facility: Väestöliitto Oulu
city: Tampere
country: Finland
facility: Tampereen Lääkärikeskus Oy
city: Tampere
country: Finland
facility: YTHS Tampere
city: Turku
country: Finland
facility: Väestöliitto Turku
Study officials:
affiliation: Väestöliitto Helsinki
name: Dan Apter, M.D.
role: PRINCIPAL_INVESTIGATOR
References: