Contraception
Conditions
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
Interventions
DRUGestetrol, 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
DRUGestetrol, 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
DRUGEstradiol 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
Sponsors
Estetra
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recording of vaginal bleeding events (diary) as a measure of Cycle control | 6 cycles of 28 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Outcome questionnaire as a measure of Subject satisfaction | 6 cycles of 28 days | — |
| Contacts patient-investigator to document Return of menstruation | 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) |
| Measurement of pregnandiol glucuronide in urine as a measure of Ovulation inhibition | 6 cycles of 28 days | — |
| Measurement of SHBG in blood samples to assess the effect of treatment on SHBG | 6 cycles of 28 days | — |
| Reporting of in-treatment pregnancies as a measure of pregnancy rate | 6 cycles of 28 days | — |
| Recording of adverse events, physical examination and laboratory parameters as a measure of Safety and Tolerability | up to 8 months | — |
Countries
Finland
Outcome results
None listed