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

NCT01256619 | Unknown Phase 2

• 1 other identifier: 132/793
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Women With PMS

Keywords

Marvelon; PMS; serum Lipids

Outcome Measures

Primary Outcomes (1)

• serum Lipids

  baseline-1 month & 2month & 3month &6month after intervention

Secondary Outcomes (1)

• PMS

  baseline-1 month & 2month & 3month &6month after intervention

Study Arms (1)

marvelon

ACTIVE COMPARATOR

Drug: Marvelon

Interventions

Marvelon DRUG

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

marvelon

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Study Sites (1)

Tehran University of Medical Sciences-BASIR center

Tehran, Tehran Province, 61-14185, Iran

RECRUITING

MeSH Terms

Interventions

Desogestrel

Intervention Hierarchy (Ancestors)

Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

seed yekaninejad, PhD

CONTACT

yekaninejad@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 7, 2010
• First Posted: December 8, 2010
• Study Start: September 1, 2010
• Primary Completion: September 1, 2010
• Last Updated: December 8, 2010

Record last verified: 2010-12

Locations

IR (1)