Evaluation of an Oral Contraceptive Containing 30 mg Ethinyloestradiol and 150 mg Desogestrel on Women's Health

December 7, 2010 updated by: Tehran University of Medical Sciences
The desogestrel (150 mg) in combination with ethinyl estradiol (EE, 30 mg) is known as Marvelon in European countries. Previous studies revealed that the Marvelon is good and safe for women. As a study from Thailand showed that the Marvelon to be effective and acceptable in Thai women. Moreover compared to Caucasian women, the incidences of irregular bleeding and side effects were apparently lower in these Asian women . Although Marvelon was used in many countries but it's efficacy didn't reported among Iranian women.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

61

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Iran, Islamic Republic of
      • Tehran, Iran, Islamic Republic of, 61-14185
        • Recruiting
        • Tehran University of Medical Sciences-BASIR center
        • Contact:
        • Principal Investigator:
          • Abbas noroozi, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

being on married, being within 18-40 years old, having normal Body mass index (ranged from 20 to 27 kg/m2), don't use any OCP during 3 months ago, having a normal menstruation cycle for the last three cycles, having at least one of following mental and behavioural symptoms ( Fatigue, mood changes, lack of energy, irritability, aggression, depression, decreased concentration, decreased social relationships, having a greed and increased appetite to eating food), having at least one of following physical symptoms (Breast sensitivity, swelling and flatulence) and women tend to use OCP for six consecutive months.

Exclusion Criteria:

pregnancy, having Anorexia or Bulimia, doing breastfeeding, smoke cigarette, Taking sleeping pills more than 3 days per month, Injection estrogen, progesterone or androgen during the past 3 months, Contraindications for OCP (including: thrombophlebitis - Severe liver disease - cerebrovascular accident and heart disease - unexplained uterine bleeding - lupus - breast cancer - migraines - sickle cell anemia - Epilepsy - gallbladder disease - kidney problems - varicocele and family history thrombosis).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: marvelon
Drug: Marvelon
The study was a clinical trial without any control group. Sixty one healthy women were included in the study. The participants had been referred to family planning clinics centers under the supervision of Tehran University of Medical Science. weight and blood pressure were measured for all participants at baseline, at the end of cycle 1, at end of cycle 2, at the end of cycle 3 and at the end of cycle 6. Blood pressure was measured on the right arm with the subject seated after 10 minutes of rest

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
serum Lipids
Time Frame: baseline-1 month & 2month & 3month &6month after intervention
baseline-1 month & 2month & 3month &6month after intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
PMS
Time Frame: baseline-1 month & 2month & 3month &6month after intervention
baseline-1 month & 2month & 3month &6month after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tehran University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (ANTICIPATED)

September 1, 2010

Study Registration Dates

First Submitted

December 7, 2010

First Submitted That Met QC Criteria

December 7, 2010

First Posted (ESTIMATE)

December 8, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

December 8, 2010

Last Update Submitted That Met QC Criteria

December 7, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 132/793

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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