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Premenstrual Symptoms Treatment Comparing Between Oral Contraceptives Containing Desogestrel and Drospirenone

Primary Purpose

Premenstrual Syndrome

Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
EE 20 microgram with desogestrel 150 mg
EE 20 microgram with drospirenone 3 mg
Sponsored by
Chulalongkorn University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premenstrual Syndrome focused on measuring PMS, Low-dose combine contraceptives pills, COC

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Family Unit, King Chulalongkorn Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DSG

DRSP

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Women's Health Assessment Questionnaire (WHAQ)score

Secondary Outcome Measures

Full Information

First Posted
November 27, 2011
Last Updated
March 13, 2012
Sponsor
Chulalongkorn University
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1. Study Identification

Unique Protocol Identification Number
NCT01482338
Brief Title
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

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chulalongkorn University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premenstrual Syndrome
Keywords
PMS, Low-dose combine contraceptives pills, COC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DSG
Arm Type
Experimental
Arm Description
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.
Arm Title
DRSP
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
EE 20 microgram with desogestrel 150 mg
Other Intervention Name(s)
Mercilon
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
EE 20 microgram with drospirenone 3 mg
Other Intervention Name(s)
Yaz
Intervention Description
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.
Primary Outcome Measure Information:
Title
Women's Health Assessment Questionnaire (WHAQ)score
Time Frame
8 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jirath Wichianpitaya, M.D.
Organizational Affiliation
Chulalongkorn University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Surasak Taneepanichskul, M.D.
Organizational Affiliation
Chulalongkorn University
Official's Role
Study Chair
Facility Information:
Facility Name
Family Unit, King Chulalongkorn Memorial Hospital
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
10830769
Citation
Sveindottir H, Backstrom T. Prevalence of menstrual cycle symptom cyclicity and premenstrual dysphoric disorder in a random sample of women using and not using oral contraceptives. Acta Obstet Gynecol Scand. 2000 May;79(5):405-13. doi: 10.1080/j.1600-0412.2000.079005405.x.
Results Reference
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PubMed Identifier
16206030
Citation
Kurshan N, Neill Epperson C. Oral contraceptives and mood in women with and without premenstrual dysphoria: a theoretical model. Arch Womens Ment Health. 2006 Jan;9(1):1-14. doi: 10.1007/s00737-005-0102-z. Epub 2005 Oct 5.
Results Reference
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PubMed Identifier
16734317
Citation
Winer SA, Rapkin AJ. Premenstrual disorders: prevalence, etiology and impact. J Reprod Med. 2006 Apr;51(4 Suppl):339-47.
Results Reference
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PubMed Identifier
15037415
Citation
Paoletti AM, Lello S, Fratta S, Orru M, Ranuzzi F, Sogliano C, Concas A, Biggio G, Melis GB. Psychological effect of the oral contraceptive formulation containing 3 mg of drospirenone plus 30 microg of ethinyl estradiol. Fertil Steril. 2004 Mar;81(3):645-51. doi: 10.1016/j.fertnstert.2003.08.030.
Results Reference
background
PubMed Identifier
11249391
Citation
New PMS guidelines released. Recommendations focus on diagnosis and treatment. AWHONN Lifelines. 2000 Jun-Jul;4(3):61-2. doi: 10.1111/j.1552-6356.2000.tb01435.x.
Results Reference
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PubMed Identifier
5812581
Citation
Moos RH. Typology of menstrual cycle symptoms. Am J Obstet Gynecol. 1969 Feb 1;103(3):390-402. doi: 10.1016/0002-9378(69)90499-2. No abstract available.
Results Reference
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PubMed Identifier
8842582
Citation
Spona J, Elstein M, Feichtinger W, Sullivan H, Ludicke F, Muller U, Dusterberg B. Shorter pill-free interval in combined oral contraceptives decreases follicular development. Contraception. 1996 Aug;54(2):71-7. doi: 10.1016/0010-7824(96)00137-0.
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PubMed Identifier
1042815
Citation
Tuckwell P. Schooling the subnormal child. The Massachusetts System. Nurs Mirror Midwives J. 1975 Sep 18;141(12):73-4. No abstract available.
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PubMed Identifier
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Citation
Pearlstein TB, Bachmann GA, Zacur HA, Yonkers KA. Treatment of premenstrual dysphoric disorder with a new drospirenone-containing oral contraceptive formulation. Contraception. 2005 Dec;72(6):414-21. doi: 10.1016/j.contraception.2005.08.021. Epub 2005 Nov 2.
Results Reference
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PubMed Identifier
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Citation
Winkler UH, Ferguson H, Mulders JA. Cycle control, quality of life and acne with two low-dose oral contraceptives containing 20 microg ethinylestradiol. Contraception. 2004 Jun;69(6):469-76. doi: 10.1016/j.contraception.2003.12.017.
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Citation
Sulak PJ, Carl J, Gopalakrishnan I, Coffee A, Kuehl TJ. Outcomes of extended oral contraceptive regimens with a shortened hormone-free interval to manage breakthrough bleeding. Contraception. 2004 Oct;70(4):281-7. doi: 10.1016/j.contraception.2004.04.007.
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PubMed Identifier
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Citation
Lopez LM, Kaptein AA, Helmerhorst FM. Oral contraceptives containing drospirenone for premenstrual syndrome. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD006586. doi: 10.1002/14651858.CD006586.pub3.
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Premenstrual Symptoms Treatment Comparing Between Oral Contraceptives Containing Desogestrel and Drospirenone

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