Premenstrual Symptoms Treatment Comparing Between Oral Contraceptives Containing Desogestrel and Drospirenone

Premenstrual Syndrome Clinical Trial

Official title:

A Comparative Efficacy of Low-dose Combine Oral Contraceptives Containing Desogestrel 150 mg and Drospirenone 3 mg on Premenstrual Symptoms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01482338
• Other study ID #: PMS 068/54
• Status: Completed
• Phase: Phase 4
• First received: November 27, 2011
• Last updated: March 13, 2012
• Start date: June 2011
• Est. completion date: March 2012

Study information

• Verified date: March 2012
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Premenstrual Syndrome

Intervention

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.
• 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.

Locations

Country	Name	City	State
Thailand	Family Unit, King Chulalongkorn Memorial Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

References & Publications (13)

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. Epub 2005 Oct 5. Review. — View 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. Review. Update in: Cochrane Database Syst Rev. 2012;2:CD006586. — View Citation

Moos RH. Typology of menstrual cycle symptoms. Am J Obstet Gynecol. 1969 Feb 1;103(3):390-402. — View Citation

New PMS guidelines released. Recommendations focus on diagnosis and treatment. AWHONN Lifelines. 2000 Jun-Jul;4(3):61-2. — View Citation

Paoletti AM, Lello S, Fratta S, Orrù 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. — View 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. Epub 2005 Nov 2. — View Citation

Spona J, Elstein M, Feichtinger W, Sullivan H, Lüdicke F, Müller U, Düsterberg B. Shorter pill-free interval in combined oral contraceptives decreases follicular development. Contraception. 1996 Aug;54(2):71-7. — View 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. — View Citation

Sulak PJ, Scow RD, Preece C, Riggs MW, Kuehl TJ. Hormone withdrawal symptoms in oral contraceptive users. Obstet Gynecol. 2000 Feb;95(2):261-6. — View Citation

Sveindóttir H, Bäckström 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. — View Citation

Tuckwell P. Schooling the subnormal child. The Massachusetts System. Nurs Mirror Midwives J. 1975 Sep 18;141(12):73-4. — View Citation

Winer SA, Rapkin AJ. Premenstrual disorders: prevalence, etiology and impact. J Reprod Med. 2006 Apr;51(4 Suppl):339-47. Review. — View 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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Women's Health Assessment Questionnaire (WHAQ)score		8 months	No