Premenstrual Symptoms Treatment Comparing Between Oral Contraceptives Containing Desogestrel and Drospirenone

Phase 4

Completed

• Conditions: Premenstrual Syndrome
• Interventions: Drug: EE 20 microgram with desogestrel 150 mg; Drug: EE 20 microgram with drospirenone 3 mg

• Registration Number: NCT01482338
• Lead Sponsor: Chulalongkorn University

Brief Summary

The purpose of this study is to determine whether low-dose combine oral contraceptives (COC) containing desogestrel 150 mg and drospirenone 3 mg are effective in the treatment of Premenstrual symptoms.

Detailed Description

Premenstrual syndrome is commonly reported 20-90 percent in reproductive-aged women. Only a small percentage of women (2 to 5%) have significant premenstrual symptoms defined as Premenstrual dysphoric disorder (PMDD). The exact symptoms and their intensity vary from woman to woman and even from cycle to cycle.While exact causes of PMS are not fully understood,current thinking suspects that fluctuation of endogenous sex hormones are relevant. The standard 21/7 design may induce menstrual-related symptoms including headache, mood swings, abdominal cramping, bloating, and breast tenderness that increase during the last week of active pills extending along the 7-day hormone free interval(HFI). The decline in endogenous estradiol levels during HFI may be responsible for the estrogen-withdrawal symptoms. While a new COC with drospirenone introduced in 24/4 design has been shown in clinical trials to significantly improve the symptoms of PMS, there has been questioned about efficacy of the other kind of COC which has optimal properties, for example, good-control cycles extend to the similar 24/4 regimen.

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-11-27
• Study First Submitted QC: 2011-11-29
• Study First Posted: 2011-11-30
• Primary Completion: 2012-02
• Status Verified: 2012-03
• Study Completion: 2012-03
• Last Update Submitted: 2012-03-13
• Last Update Posted: 2012-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

• age 18-35years
• Regular menses, I:21-35 days
• Willingness to take COC for 6 months
• No history of COC in last 6 months
• No history of injected contraception in last 6 months
• History of implant contraception need to have regular menses 3 cycles
• History of miscarriage need to have regular menses 3 cycles

Exclusion Criteria

• Pregnant or suspected pregnant
• Breast feeding
• Smoking
• Contraindication of WHO 2,3 and 4
• PMDD

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DSG	EE 20 microgram with desogestrel 150 mg	The low-dose oral contraceptive pill which one consists of 20 microgram ethinyl estradiol and 150 mg desogestrel were taken orally by participants every day beginning Day1 to Day 3 of the first menstrual cycle until complete 24 days and continued with free-hormone pills for 4 days. The next cycle has to continue in the same way until complete 6 cycles.
DRSP	EE 20 microgram with drospirenone 3 mg	The other low-dose oral contraceptive pill which consists of 20 microgram ethinyl estradiol and 3 mg drospirenone were taken orally by participants every day beginning Day1 to Day 3 of the first menstrual cycle until complete 24 days and continued with free-hormone pills for 4 days. The next cycle has to continue in the same way until complete 6 cycles.

Primary Outcome Measures

Name	Time	Method
Women's Health Assessment Questionnaire (WHAQ)score	8 months

Trial Locations

Locations (1)

Family Unit, King Chulalongkorn Memorial Hospital; 🇹🇭 Bangkok, Thailand