Safety, hemostatic and metabolic effects and contraceptive efficacy of an oral monophasic contraceptive containing 0.03 mg ethinylestradiol and 2 mg chlormadinone acetate (CG5025) used in two different regimens of intake - Not available

Phase 1

• Conditions: Wish for contraception

• Registration Number: EUCTR2004-002076-42-HU
• Lead Sponsor: Grünenthal GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-11-24
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 1012

Inclusion Criteria

- Healthy, sexual active woman of child-bearing potential aged 18 - 40 years (non smoker) or 18 - 35 years (smoker) at admission
- Laboratory values with no deviations of any clinical relevance for the course of the study in the opinion of the investigator
- Wish for oral contraception for at least 392 days
- BMI = 30
- HEMOSTATIC/METABOLIC SUBGROUP:
- Healthy, non-smoking, sexual active woman of child-bearing potential aged 18 - 40 years at admission
- Wish for oral contraception for at least 392 days followed by approximately 2 months with a barrier method, e.g. condoms

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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

General criteria
- Pregnancy
- Breast feeding
- Evidence or history of alcohol, medication or drug dependency
- Severe psychiatric illness, epilepsy or suicide risk
- Any chronic disease (e.g. hepatic and/or renal) or diet that might affect drug absorption, metabolism or excretion

Study specific
- Planned surgery requiring withdrawal of an oral contraceptive during the anticipated time of participation in this study
- Cytologic evidence of intraepithelial neoplasia in a cervical smear (e.g. Pap smear grade III to V)
- Unexplained amenorrhea or genital bleeding
-Known polycystic ovary syndrome, anovulatory cycles, hysterectomy, bilateral oophorectomy
- Administration of any other hormonal contraceptives including patches and vaginal rings during the medication cycles
- Use of intra-uterine devices (IUD) with or without hormone impregnation during the medication cycles
- Use of implantable contraceptives during the medication cycles
- Use of injectable contraceptives within the preceding 6 months (date of injection) before admission and during the medication cycles
- Use of estrogen or progesterone containing medication during the medication cycles
- Regular concomitant use of a barrier method
- Migraine with focal neurological symptoms (migraine accompagnée)
- Need for concomitant treatment (longer than 5 days) with
• medicines that increase gastrointestinal motility (e.g. metoclopramide) or impair absorption (e.g. activated charcoal)
• active substances inducing microsomal enzymes in the liver such as rifampicin, rifabutin, barbiturates, anti-epileptics (e.g. phenytoin, carbamazepine, oxcarbazepine, topiramate, felbamate, primidone, barbexaclone), griseofulvin, modafinil, protease inhibitors (e.g. ritonavir), or St. John’s Wort
• antibiotics

- Hepatic diseases
- Circulation affecting and metabolic diseases
- Pancreatitis or history of such a condition, if associated with severe hypertriglyceridemia
- Tumors: presence, history or suspicion of any malignant or hormone-sensitive tumor
- Other diseases:
• Porphyria (in particular acquired hepatic porphyria)
• Otosclerosis deteriorating in previous pregnancies
• Acute sensory disorders, e.g. visual or hearing disorders
• Motor disorders, particularly paresis
• Severe epigastric pain, enlargement of the liver, or symptoms of intraabdominal hemorrhage

Study specific for volunteers in hemostatic/metabolic subgroup
- Use of oral contraceptives, contraceptive vaginal rings, or contraceptive patches within 1 cycle before the pre-medication cycle
- Concomitant and prior use of intra-uterine devices (IUD) with or without hormone impregnation within 1 cycle before the pre-medication cycle
- Use of implantable contraceptives within the preceding 2 cycles before the pre-medication cycle
- Parturition, miscarriage, or abortion within the preceding 3 months before the baseline visit
- Concomitant use of anticoagulants, i.e. heparins and coumarins
- Concomitant medications affecting the lipoprotein and/or carbohydrate metabolism (e.g. systemic glucocorticoides, ß-blockers, thiazide diuretics, antilipemic agents)
- Concomitant diseases affecting the lipoprotein and/or carbohydrate metabolism (e.g. diabetes mellitus, hypothyroidism, cholestasis, nephrotic syndrome, renal insufficiency requiring hemodialysis)
- Fasting total cholesterol > 6.47 mmol/l (> 250 mg/dl) and/or triglycerides > upper limit of normal at baseline
- Concomitant use of platelet aggregation inhibitors and/or non-steroidal anti-i

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Secondary Objective: not applicable;Primary end point(s): - number of days with intermenstrual bleeding related to the number of potential days with intermenstrual bleeding during 392 days,<br>- total number of days with bleeding during 392 days and within each of 4 reference periods of 98 days,<br>- intensity of bleeding<br>;Main Objective: The objective of this study is to show that the safety and efficacy of an extended oral contraceptive treatment with Belara/CG5025 taken for two 196-days cycles (189 days with active pill intake plus 7 days pill-free interval) is comparable with the safety and efficacy of the conventional treatment, i.e. Belara/CG5025 taken for fourteen 28-days cycles (21 days with active pill intake plus 7 days pill-free interval), where in the EC group the mean number of days with intermenstrual bleeding related to the number of potential days with intermenstrual bleeding does not exceed 16.0% during two ECs.