Post-marketing, Observational Study to Confirm the Safety and Efficacy of MARVELON (Study P06083)

Contraception Clinical Trial

Official title:

Drug Use Investigation of MARVELON

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01005056
• Other study ID #: P06083
• Status: Completed
• Start date: May 2005
• Est. completion date: March 2009

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of Marvelon® in the prevention of pregnancy.

Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.

Description:

Women with willingness to prevent pregnancy, who do not meet any of the contraindications, and who will take Marvelon® in compliance with the approved dosage and administration method will be enrolled.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3838
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Women with willingness to prevent pregnancy and to take Marvelon® in compliance with the approved dosage and administration method

Exclusion Criteria:

• Women with constitution of hypersensitivity to ingredients of this product.

• Woman with estrogen-dependent tumor (for instance, breast cancer, cancer of uterine body and uterine myoma), cancer of uterine cervix, or suspected of them. [aggravation or manifestation of tumor may be induced.]

• Patients with abnormal genital bleeding for which diagnosis has not been established [Genital cancer is suspected. If bleeding is due to genital cancer, aggravation or manifestation of cancer may be induced.]

• Patients with thrombophlebitis, embolism pulmonary, cerebrovascular disorder, coronary diseases, or a history thereof [blood coagulation capacity may be increased and these symptoms may be aggravated.]

• Smoker aged 35 years or older taking 15 or more pieces of tobacco per day [It has been reported that cardiovascular disorder including myocardial infarction is liable to occur.]

• Patients with migraine accompanied by signal symptom (scotoma scintillans, star-shaped flash, etc.) [It has been reported that compared with patients without concomitant symptom, in patients with concomitant symptom cerebrovascular accidents (apoplectic ictus, etc.) are more prone to occur.]

• Patients with heart valve disease accompanied by pulmonary hypertension or fibrillary waves. Patients with heart valve disease with a history of acute bacterial endocardiosis [It has been reported that cardiovascular disorders such as thrombosis, etc. are liable to occur.]

• Patients with diabetes accompanied by vascular lesion (diabetic nephropathy, diabetic retinopathy, etc.) [It has been reported that cardiovascular disorders such as thrombosis, etc. are liable to occur.]

• Women with constitution of thrombosis [It has been reported that cardiovascular disorders including thrombosis, etc. are liable to occur.]

• Patients with antiphospholipid antibody syndrome [It has been reported that cardiovascular disorders including thrombosis, etc. are liable to occur.]

• Patient within 4 weeks before operation, within 2 weeks after operation, within 4 weeks of after delivery or at rest for a long-term period [Blood coagulation capacity is increased and the risk of occurrence of adverse reactions in the cardiovascular system may become high.]

• Patients with serious hepatic disorder [Since metabolic capacity is decreased, the burden on the liver increases, and the symptom may be aggravated.]

• Patients with hepatic tumor [The symptom may be aggravated.]

• Patients with lipid metabolism disorder [It has been reported that cardiovascular disorders including thrombosis, etc. are liable to occur. Since there is a possibility of lipid metabolism being affected, the symptom may be aggravated.]

• Patients with hypertension (excluding mild hypertension) [It has been reported that cardiovascular disorders including thrombosis, etc. are liable to occur. The symptom may be aggravated.]

• Patients with otosclerosis [The symptom may be aggravated.]

• Patients with a history of jaundice, persisting itching or gestational herpes during pregnancy [The symptom may be aggravated.]

• Pregnant or possibly pregnant women [Refer to the section "Use during Pregnancy, Delivery or Lactation".]

• Lactating women [Refer to the section "Use during Pregnancy, Delivery or Lactation".]

• Women before puberty [Early epiphysiodesis may occur.]

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• Ethinylestradiol + Desogestrel
All participants receive Marvelon® according to the approved dosage and administration method.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants who did not get pregnant during the study.		End of every 12 menstrual cycles up to 36 or at the termination of drug administration.