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

NCT ID: NCT01256619

Last Updated: 2010-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Brief Summary

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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

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Conditions

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Women With PMS

Keywords

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Marvelon PMS serum Lipids

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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marvelon

Group Type ACTIVE_COMPARATOR

Marvelon

Intervention Type 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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Tehran University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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BASIR center

Locations

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Tehran University of Medical Sciences-BASIR center

Tehran, Tehran Province, Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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seed yekaninejad, PhD

Role: CONTACT

Email: [email protected]

Facility Contacts

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abbas noroozi, PhD

Role: primary

Other Identifiers

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132/793

Identifier Type: -

Identifier Source: org_study_id