Clinical trial NCT01482338: Premenstrual Symptoms Treatment Comparing Between Oral Contraceptives Containing Desogestrel and Drospirenone
Official title: A Comparative Efficacy of Low-dose Combine Oral Contraceptives Containing Desogestrel 150 mg and Drospirenone 3 mg on Premenstrual Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Premenstrual Syndrome
Keywords: PMS
Low-dose combine contraceptives pills
COC
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2011-11-30
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Women's Health Assessment Questionnaire (WHAQ)score
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Family Unit, King Chulalongkorn Memorial Hospital
Study officials:
affiliation: Chulalongkorn University
name: Jirath Wichianpitaya, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Chulalongkorn University
name: Surasak Taneepanichskul, M.D.
role: STUDY_CHAIR
References:
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