EUCTR2013-002300-13-BG
Active, not recruiting
Not Applicable
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 - Endometrium effect of an oral preparation containing 4 mg drospirenone
CHEMO France0 sitesSeptember 26, 2013
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- CHEMO France
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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 \<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
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
Outcomes
Primary Outcomes
Not specified
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