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

NCT ID: NCT01221831

Last Updated: 2012-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 396 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2011-09-30

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

Conditions

Contraception

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

estetrol dose 1 / P1

Group Type: EXPERIMENTAL

estetrol, P 1 and placebo tablets

Intervention Type: 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 dose 1 / P2

Group Type: EXPERIMENTAL

estetrol, P2 and placebo tablets

Intervention Type: 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 pill

Group Type: ACTIVE_COMPARATOR

Estradiol valerate, dienogest and placebo tablets

Intervention Type: 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

estetrol dose 2 / P1

Group Type: EXPERIMENTAL

estetrol, P 1 and placebo tablets

Intervention Type: 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 dose 2 / P2

Group Type: EXPERIMENTAL

estetrol, P2 and placebo tablets

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

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

Intervention Type: DRUG

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Estetra

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dan Apter, M.D.

Role: PRINCIPAL_INVESTIGATOR

Väestöliitto Helsinki

Locations

Mehiläinen Helsinki

Helsinki, , Finland

Väestöliitto Helsinki

Helsinki, , Finland

YTHS Jyvaskyla

Jyväskylä, , 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, , Finland

Countries

Finland

Other Identifiers

2010-019865-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ES-C02

Identifier Type: -

Identifier Source: org_study_id