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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-019865-26 | EudraCT Number |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| estetrol dose 1 / P1 | Experimental |
| |
| estetrol dose 1 / P2 | Experimental |
| |
| estradiol valerate/dienogest pill | Active Comparator |
| |
| estetrol dose 2 / P1 | Experimental |
| |
| estetrol dose 2 / P2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| estetrol, P 1 and placebo tablets | Drug | 6 treatment cycles each consisting of 28 days of oral administration as follows:
|
| Measure | Description | Time Frame |
|---|---|---|
| Recording of vaginal bleeding events (diary) as a measure of Cycle control | 6 cycles of 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of pregnandiol glucuronide in urine as a measure of Ovulation inhibition | 6 cycles of 28 days | |
| Patient Reported Outcome questionnaire as a measure of Subject satisfaction | 6 cycles of 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dan Apter, M.D. | Väestöliitto Helsinki | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mehiläinen Helsinki | Helsinki | Finland | ||||
| Väestöliitto Helsinki |
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| estetrol, P2 and placebo tablets | Drug | 6 treatment cycles each consisting of 28 days of oral administration as follows:
|
|
| Estradiol valerate, dienogest and placebo tablets | Drug | 6 treatment cycles each consisting of 28 days of oral administration as follows:
|
|
| 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 |
| Recording of adverse events, physical examination and laboratory parameters as a measure of Safety and Tolerability | up to 8 months |
| 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 |
| 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 |
| ID | Term |
|---|---|
| D004953 | Estetrol |
| C020845 | P-2 |
| D004958 | Estradiol |
| C023635 | dienogest |
| ID | Term |
|---|---|
| D004964 | Estriol |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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