Assessing the endometrial safety of an oral test preparation containing 4 mg drospirenone, which is usually used as contraceptive. MedDRA version: 16.0 Level: PT Classification code 10030970 Term: Oral contraception System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Product Name: Drospirenone 4 mg film-coated tablet
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Drospirenone
CAS Number: 67392-87-4
Other descriptive name: DROSPIRENONE
Concentration u
Sponsors
CHEMO France
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy woman at risk of pregnancy 2. Age between 18 and 40 years at inclusion 3. At least four menstrual cycles during the last six months before screening were regular (i.e. cycle length between 24 and 35 days) in women previously not taking oral contraceptives (“Starter”) 4. At least one regular menstrual cycle after the end of previous intake of oral contraceptives (“Switcher”) 5. Systolic blood pressure =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Hypersensitivity to the active substances or to any of the ingredients or excipients (for a list of ingredients and excipients see the Investigator’s brochure) 2. Pregnant or breastfeeding subject 3. Abnormal finding on pelvic, breast or ultrasound endometrial examination that precludes participation in the trial 4. Abnormal endometrial biopsy 5. Unexplained amenorrhea, known polycystic ovary syndrome 6. Papanicolaou cervical smear finding of atypical squamous cells of undetermined significance (ASC-US) or more severe according to the Bethesda system terminology 7. Significant cardiovascular, hepatic or renal disease 8. Diabetes with vascular involvement 9. Uncontrolled thyroid disorder 10. Current venous thrombosis 11. Known bleeding disorder or history of unexplained bleeding or bruising within the last 12 months prior to screening 12. Prohibited previous or concomitant medication: 12.1 Injectable hormonal methods of contraception within the last 6 months before screening and during the trial 12.2 Progestin-releasing intrauterine device or contraceptive implant within the last 2 months before screening and during the trial 12.3 Anti-retroviral therapy within the last 6 months before screening and during the trial 12.4 Estrogens during the trial 12.5 Progestogens during the trial 12.6 Activated charcoal taken within 3 hours before or after intake of the study drug 12.7 Longer than 5 days treatment during the trial with drugs or herbal products that may decrease the effectiveness of hormonal contraceptives (e.g. anticonvulsants like phenytoin, carbamazepine, oxcarbazepine, topiramate, felbamate, primidone) or barbiturates, rifampicin, atorvastatin, bosentan, griseofulvin,·phenylbutazone, St. John’s wort (hypericum perforatum), medications that may increase serum potassium (ACE inhibitors, angiotensin – II receptor antagonists, potassiumsparing diuretics, potassium supplementation, heparin, aldosterone antagonists and NSAIDs) 13. Simultaneous participation in another clinical study or participation in any clinical study involving an investigational drug within 3 months prior to start of the present study 14. Employee of the investigator or trial center, with direct involvement in the proposed trial or other studies under the direction of that investigator or trial center, or family member of the employees or the investigator 15. Severe physical or mental concomitant diseases that might hamper the realization of the trial according to protocol 16. History of alcohol or drug addiction 17. Legal incapacity and/or other circumstances rendering the subject unable to understand the nature, scope and possible consequences of the study 18. Unreliability or lack of cooperation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the endometrial safety of an oral test preparation containing 4 mg drospirenone (Test IMP: Drospirenone 4 mg film-coated tablet) after multiple dose administration of 4 mg drospirenone for a total duration of 13 cycles of 28 days each: 24 days of active treatment followed by 4 days placebo treatment per treatment cycle.;Secondary Objective: - To assess the endometrial thickness under treatment with the test product, - To assess the pattern of vaginal bleeding under treatment with the test product, - To assess the safety of the test product on the basis of safety clinical and laboratory examinations (at the beginning and at the end of the trial) and registration of adverse events and/or adverse drug reactions based on evaluation of adverse events.;Primary end point(s): Rating of endometrial biopsy (according to Lindgren et al., 1992). This endpoint undergoes descriptive statistical evaluation.;Timepoint(s) of evaluation of this end point: After end of the clinical part and database closure. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): a) Endometrial thickness measured by transvaginal sonography, b) Number and percent of subjects with scheduled bleeding, spotting, and unscheduled bleeding per cycle, c) Number and percent of days per cycle with scheduled bleeding, unscheduled bleeding, or spotting. Additional endpoints: a) Incidence of adverse events and serious adverse events, b) Changes from baseline in the results of clinical examination and vital signs c) Changes from baseline in safety laboratory parameters (hematology, blood coagulation, biochemistry, urinalysis) d) Changes from baseline in the results of gynecological examination e) Results of pregnancy tests. These endpoints undergo descriptive statistical evaluation. ;Timepoint(s) of evaluation of this end point: After end of the clinical part and database closure. | — |
Countries
Bulgaria
Contacts
Public ContactHead of Development 'Endocrinology
Dominique Drouin
Outcome results
None listed