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

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ClinicalTrials.gov Identifier: NCT01256619
Recruitment Status : Unknown
Verified December 2010 by Tehran University of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : December 8, 2010
Last Update Posted : December 8, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Women With PMS Drug: Marvelon Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 61 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : September 2010
Estimated Primary Completion Date : September 2010
Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. serum Lipids [ Time Frame: baseline-1 month & 2month & 3month &6month after intervention ]

Secondary Outcome Measures :
  1. PMS [ Time Frame: baseline-1 month & 2month & 3month &6month after intervention ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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).

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01256619


Contacts
Contact: seed yekaninejad, PhD yekaninejad@yahoo.com

Locations
Iran, Islamic Republic of
Tehran University of Medical Sciences-BASIR center Recruiting
Tehran, Iran, Islamic Republic of, 61-14185
Contact: abbas noroozi, PhD    009802166581560    noroozia@tums.ac.ir   
Principal Investigator: Abbas noroozi, PhD         
Sponsors and Collaborators
Tehran University of Medical Sciences
More Information

Responsible Party: Dr.abbas noroozi, BASIR center
ClinicalTrials.gov Identifier: NCT01256619     History of Changes
Other Study ID Numbers: 132/793
First Posted: December 8, 2010    Key Record Dates
Last Update Posted: December 8, 2010
Last Verified: December 2010

Keywords provided by Tehran University of Medical Sciences:
Marvelon
PMS
serum Lipids

Additional relevant MeSH terms:
Desogestrel
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists