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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Tehran University of Medical Sciences.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01256619
First received: December 7, 2010
Last updated: NA
Last verified: December 2010
History: No changes posted
  Purpose

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 Intervention Phase
Women With PMS
Drug: Marvelon
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • serum Lipids [ Time Frame: baseline-1 month & 2month & 3month &6month after intervention ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • PMS [ Time Frame: baseline-1 month & 2month & 3month &6month after intervention ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 61
Study Start Date: September 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr.abbas noroozi, BASIR center
ClinicalTrials.gov Identifier: NCT01256619     History of Changes
Other Study ID Numbers: 132/793
Study First Received: December 7, 2010
Last Updated: December 7, 2010
Health Authority: Iran: Ministry of Health

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

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

ClinicalTrials.gov processed this record on August 28, 2014