CClinicalTrials.gg
CompletedNCT01005056Updated Feb 4, 2022

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

An observational study in Contraception, sponsored by Organon and Co. Completed. Open to female participants. Per ClinicalTrials.gov, last updated 2022-02-04.

Sponsored by Organon and Co · Observational

Study type
Observational
Model
Ecologic or community
Time perspective
Prospective
Enrollment
3,838
Sex
Female
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Contraception
03

In context

Lead sponsor

Organon and Co is the lead sponsor of 478 studies on the registry; none are open to participants now.

Of its 21 completed or terminated interventional studies of FDA-regulated products, 17 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Participants will be selected from clinical institutions where Marvelon® was adopted and delivered.

Inclusion criteria

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

Exclusion criteria

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.]
05

Study design

Observational model
Ecologic or community
Time perspective
Prospective
Enrollment
3,838 participants (actual)
Patient registry
No

Groups and cohorts

  • Marvelon®

    Single arm study. All participants receive Marvelon® according to the approved dosage and administration method.

    Drug: Ethinylestradiol + Desogestrel

Interventions

  • DrugEthinylestradiol + Desogestrel

    All participants receive Marvelon® according to the approved dosage and administration method.

06

What researchers measure

Primary outcomes

  1. Number of participants who did not get pregnant during the study.

    Time frame: End of every 12 menstrual cycles up to 36 or at the termination of drug administration.

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 4, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01005056
Lead sponsor
Organon and Co
Responsible party
Sponsor
First posted
Oct 30, 2009
Start date
May 2005
Primary completion
Mar 2009
Completion
Mar 2009
Last update
Feb 4, 2022

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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