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Multicentre, single arm phase III trial to assess the pearl index of LVDS. The trial lasts 13 cycles.The assessments include (but are not limited to) recording demographic data, pregnancy tests, gynaecological examinations, laboratory tests and a quality of life questionnaire. Adolescents will undergo DXA scans to measure bone mineral density (at selected sites only). The women will be provided with an e-diary app for their smartphone, to record IP use and vaginal bleeding.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LVDS | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LVDS | Combination Product | Levonorgestrel Vaginal Delivery System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pearl Index | 1 year |
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Inclusion Criteria:
At Visit 1a, subjects must meet ALL of the following criteria:
Sexually active, postmenarcheal and premenopausal female subjects at risk of pregnancy including breastfeeding women.
Women who either
Only for subjects who were not pregnant and did not use hormonal contraception during the last 6 months before consent/assent:
Regular cycles (i.e. cycle length between 24 and 35 days) during the last 6 months.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LR-301/ | Móstoles | Madrid | 28938 | Spain |
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