Efficacy and Safety of a Combined Oral Contraceptive of Estradiol Valerate and Dienogest in Healthy Female Subjects

Phase 3

Active, not recruiting

• Registration Number: CTRI/2012/10/003071
• Lead Sponsor: Bayer HealthCare AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 940

Inclusion Criteria

1. Signed and dated informed consent, either by the subject or impartial witness, in case the subject is temporarily not able to sign, e.g., due to a broken hand.15

2. Healthy female subject requesting contraception.

3. Age between 18 and 40 years (inclusive). Smokers must not be older than 35 years at the time of informed consent.

4. Normal or clinically insignificant cervical smear not requiring further follow-up (a cervical smear must be obtained at the screening visit or a normal result must be documented within the previous 6 months). Human papilloma virus (HPV) testing in subjects with atypical cells of undetermined significance (ASCUS) may be used as an adjunctive test. Subjects with ASCUS may be included if they are negative for high-risk HPV strains.16

5. History of regular cyclic menstrual periods without hormonal contraceptive use

Exclusion Criteria

1. Pregnancy or lactation (less than three months since delivery, abortion, or lactation

before start of treatment)

2. Body mass index17 (BMI) 32 kg/m2

3. Hypersensitivity to any ingredient of the study drug

4. Laboratory values outside inclusion range before allocation of treatment

5. Any disease or condition that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study medication (such as but not limited to duodenal ulcers,gastritis, gastrectomy or gastric resection surgery, or renal compromise)

6. Any disease or condition that might interfere with the conduct of the study or the interpretation of the results

7. Any disease or condition that may worsen under hormonal treatment according to the assessment and opinion of the investigator. The following are examples of such conditions or diseases:

Cardiovascular

- presence or a history of venous or arterial thrombotic / thromboembolic events (e.g.,

deep venous thrombosis, pulmonary embolism, myocardial infarction) or of a

cerebrovascular accident, including prodromi (e.g., transient ischemic attack, angina

pectoris) and conditions which could increase the risk of suffering from any of the

above mentioned disorders, e.g., a family history indicating a hereditary predisposition

- repeated measurements of systolic blood pressure 140 mmHg and/or diastolic blood

pressure 90 mmHg

Liver

- presence or history of liver tumors (benign or malignant)

- presence or history of severe hepatic disease, where liver function parameter values

have not returned to normal

- jaundice and / or pruritus related to cholestasis (except Gilbertâ??s syndrome)

- history of cholestatic jaundice associated with pregnancy or previous COC use

Metabolic diseases

- uncontrolled diabetes mellitus and/or diabetes mellitus with vascular involvement

- severe dyslipoproteinemia

Other diseases

- malignant or premalignant disease

- uncontrolled thyroid disorder

- chronic inflammatory bowel disease

- severe renal insufficiency or acute renal failure

- hemolytic uremic syndrome

- sickle cell anemia

- porphyria

- history of hypertriglyceridemia-associated pancreatitis

- systemic lupus erythematosus, pemphigoid gestationis during a previous pregnancy

- Sydenham chorea

- history of herpes gestationis

- otosclerosis-related hearing loss

- history of migraine with focal neurologic symptoms

- epilepsy

- clinically significant depression

- hereditary angioedema

8. Undiagnosed abnormal genital bleeding

9. Abuse of alcohol, drugs, or medicines (e.g., laxatives)

10. Other contraceptive methods:

- sterilization

- long-acting preparations (e.g., depot- medroxyprogesterone acetate, monthly

contraceptive injection) within a period of 3 times of the injection interval before start

of treatment. The use of non-study oral, vaginal, or transdermal hormonal

contraception, intrauterine devices (IUDs) with or without hormonal release, and

implants (still in place within 30 days of Visit 1) are prohibited during tr

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary efficacy variable: <br/ ><br>The primary efficacy variable is the dichotomous variable: pregnancy, present or not present.Timepoint: After 13 treatment cycles

Secondary Outcome Measures

Name	Time	Method
Analysis of cycle control and bleeding pattern parameters from <br/ ><br>admission to the study until Cycle 13Timepoint: After 13 treatment cycles