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Trial record 6 of 53 for:    DROSPIRENONE AND ETHINYL ESTRADIOL AND containing

Premenstrual Symptoms Treatment Comparing Between Oral Contraceptives Containing Desogestrel and Drospirenone

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01482338
Recruitment Status : Completed
First Posted : November 30, 2011
Last Update Posted : March 14, 2012
Sponsor:
Information provided by (Responsible Party):
Jirath Wichianpitaya,MD., Chulalongkorn University

Tracking Information
First Submitted Date  ICMJE November 27, 2011
First Posted Date  ICMJE November 30, 2011
Last Update Posted Date March 14, 2012
Study Start Date  ICMJE June 2011
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 29, 2011)
Women's Health Assessment Questionnaire (WHAQ)score [ Time Frame: 8 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01482338 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Premenstrual Symptoms Treatment Comparing Between Oral Contraceptives Containing Desogestrel and Drospirenone
Official Title  ICMJE A Comparative Efficacy of Low-dose Combine Oral Contraceptives Containing Desogestrel 150 mg and Drospirenone 3 mg on Premenstrual Symptoms
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Premenstrual Syndrome
Intervention  ICMJE
  • Drug: EE 20 microgram with desogestrel 150 mg
    Comparison of 2 different low-dose oral contraceptive pill which one consists of 20 microgram ethinyl estradiol and 150 mg desogestrel and the other consists of 20 microgram ethinyl estradiol and 3 mg drospirenone. Both 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.
    Other Name: Mercilon
  • Drug: EE 20 microgram with drospirenone 3 mg
    Comparison of 2 different low-dose oral contraceptive pill which one consists of 20 microgram ethinyl estradiol and 150 mg desogestrel and the other consists of 20 microgram ethinyl estradiol and 3 mg drospirenone. Both 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.
    Other Name: Yaz
Study Arms  ICMJE
  • Experimental: DSG
    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.
    Intervention: Drug: EE 20 microgram with desogestrel 150 mg
  • Active Comparator: DRSP
    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.
    Intervention: Drug: EE 20 microgram with drospirenone 3 mg
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 29, 2011)
90
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2012
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01482338
Other Study ID Numbers  ICMJE PMS 068/54
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jirath Wichianpitaya,MD., Chulalongkorn University
Study Sponsor  ICMJE Chulalongkorn University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jirath Wichianpitaya, M.D. Chulalongkorn University
Study Chair: Surasak Taneepanichskul, M.D. Chulalongkorn University
PRS Account Chulalongkorn University
Verification Date March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP