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| Name | Class |
|---|---|
| SocraTec R&D GmbH | OTHER |
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This clinical trial is performed as proof of pharmacological action investigation by demonstration of ovulation inhibition (dose-response study) under treatment with three Test vaginal rings releasing varying doses of estriol (E3) and trimegestone (TMG).
Blood samples for determination of estradiol (E2) and progesterone (PG) levels will serve as pharmacodynamic surrogate parameters for characterization of the treatment effect on the endogenous hormones.
Blood samples for determination of E3 and TMG in plasma will be collected in order to characterize pharmacokinetic parameters.
Additionally, local tolerability characterized by gynecological inspection of the vaginal mucosa prior to and after insertion of the Investigational Medicinal Product (IMPs) is planned to be assessed
The IMPs, releasing either 0.400 mg E3 and 0.06 mg TMG, or 0.300 mg E3 and 0.12 mg TMG, or 0.200 mg E3 and 0.18 mg TMG per 24 h, will be applied intravaginally and remain in the vagina for the subsequent 21 days (single dose, 1 treatment cycle). A total of 36 female subjects, 12 per treatment group, are intended to be randomized.
Blood samples for determination of E2 and PG levels will be collected during treatment and until 20 days after removal of the ring. Blood samples for determination of E3 and TMG in plasma will be collected over the treatment period and until 48 h after removal of the ring.
Bleeding intensity will also be documented during treatment and until 20 days after removal of the vaginal ring in a diary to characterize the effects of the different treatments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test 1 vaginal ring | Experimental | Single intravaginal application of 1 vaginal ring of Estriol 0.400 mg/day and Trimegestone 0.06 mg/day (Test 1) over 21 days |
|
| Test 2 vaginal ring | Experimental | Single intravaginal application of 1 vaginal ring of Estriol 0.300 mg/day and Trimegestone 0.12 mg/day (Test 2) over 21 days |
|
| Test 3 vaginal ring | Experimental | Single intravaginal application of 1 vaginal ring of Estriol 0.200 mg/day and Trimegestone 0.18 mg/day (Test 3) over 21 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Estriol 0.400 mg/day and Trimegestone 0.06 mg/day | Drug | Vaginal ring with a nominal delivery rate of 0.400 mg/d estriol (E3) and 0.06 mg/d trimegestone (TMG), vaginal application |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of E2 and PG plasma levels | Blood sampling for the determination of plasma levels of E2 and PG, in participants of each treatment group, as surrogate variables for treatment response. | 0 - 41 days |
| Measurement of E3 and TMG plasma levels | Blood sampling for the determination of plasma levels of E3 and TMG, in participants of each treatment group. | 0 - 23 days |
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding intensity | Bleeding intensity, graded as "no bleeding", "spotting" or "bleeding" as recorded in diary by the subject on a daily basis | start of treatment until 42 days after treatment |
| Number of adverse events per participant |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gilberto De Nucci, MD | Galeno Desenvolvimento de Pesquisas Clinicas Ltda. - ME | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galeno Desenvolvimento de Pesquisas Clinicas Ltda. - ME | Campinas | São Paulo | Brazil |
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Single centre, open-label, randomized (assignment to treatment group), parallel-group, three-arm single-dose clinical trial with application performed over 1 treatment cycle of 21 days.
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| Estriol 0.300 mg/day and Trimegestone 0.12 mg/day | Drug | Vaginal ring with a nominal delivery rate of 0.300 mg/d estriol (E3) and 0.12 mg/d trimegestone (TMG), vaginal application |
|
| Estriol 0.200 mg/day and Trimegestone 0.18 mg/day | Drug | Vaginal ring with a nominal delivery rate of 0.200 mg/d estriol (E3) and 0.18 mg/d trimegestone (TMG), vaginal application |
|
Number of adverse events, in each treatment group, including clinically relevant alterations of vital signs and laboratory tests results
| up to 42 days after treatment |
| Maximum Plasma Concentration (Cmax) of E3 and TMG | Determination of Cmax for E3 and for TMG, based on plasma concentrations of samples obtained. | 0 - 23 days |
| Area Under the Curve (AUC) for E3 and TMG | Calculation of the AUC for E3 and for TMG, based on plasma concentrations of samples obtained | 0 - 23 days |
| ID | Term |
|---|---|
| D004964 | Estriol |
| C050319 | trimegestone |
| ID | Term |
|---|---|
| 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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