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

Phase 2

• Conditions: Women With PMS
• Interventions: Drug: Marvelon

• Registration Number: NCT01256619
• Lead Sponsor: Tehran University of Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Primary Completion: 2010-09
• Status Verified: 2010-12
• Study First Submitted: 2010-12-07
• Study First Submitted QC: 2010-12-07
• Last Update Submitted: 2010-12-07
• Study First Posted: 2010-12-08
• Last Update Posted: 2010-12-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 61

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
marvelon	Marvelon	-

Primary Outcome Measures

Name	Time	Method
serum Lipids	baseline-1 month & 2month & 3month &6month after intervention

Secondary Outcome Measures

Name	Time	Method
PMS	baseline-1 month & 2month & 3month &6month after intervention

Trial Locations

Locations (1)

Tehran University of Medical Sciences-BASIR center; 🇮🇷 Tehran, Iran, Islamic Republic of