A study to evaluate the effect on the endometrium of a new formulation containing 4 mg drospirenone (Drospirenone 4 mg film-coated tablet) administered over a period of 13 cycles. A monocentric, open, multiple dose trial in healthy female subjects at risk of pregnancy

• Conditions: Assessing the endometrial safety of an oral test preparation containing 4 mg drospirenone, which is usually used as contraceptive.; MedDRA version: 16.0Level: PTClassification code 10030970Term: Oral contraceptionSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]

• Registration Number: EUCTR2013-002300-13-BG
• Lead Sponsor: CHEMO France

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-26
• Last Update Posted: 17 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: Not specified

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 <140 mmHg, diastolic blood pressure <90 mmHg, in sitting position, after 5 minutes of rest
6. Subject agrees to use the test product for contraception for at least 13 cycles
7. Menstruation restarted since last pregnancy (only applicable for women that were pregnant)
8. Laboratory values at screening with no deviations of any clinical relevance in the opinion of the investigator
9. Subjects with ability to follow study instructions and likely to attend and complete all required visits
10. Informed consent given in written form according to chapter 5.4 of the study protocol
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 22
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified