Premenstrual Symptoms Treatment Comparing Between Oral Contraceptives Containing Desogestrel and Drospirenone

NCT01482338 | Completed Phase 4

• 1 other identifier: PMS 068/54
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Premenstrual Syndrome

Keywords

PMS; Low-dose combine contraceptives pills; COC

Outcome Measures

Primary Outcomes (1)

• Women's Health Assessment Questionnaire (WHAQ)score

  8 months

Study Arms (2)

DSG

EXPERIMENTAL

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.

Drug: EE 20 microgram with desogestrel 150 mg

DRSP

ACTIVE COMPARATOR

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.

Drug: EE 20 microgram with drospirenone 3 mg

Interventions

EE 20 microgram with desogestrel 150 mg DRUG

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.

Also known as: Mercilon

DSG

EE 20 microgram with drospirenone 3 mg DRUG

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.

Also known as: Yaz

DRSP

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

Family Unit, King Chulalongkorn Memorial Hospital

Bangkok, Bangkok, 10330, Thailand

Location

Related Publications (13)

• 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.

  PMID: 10830769 BACKGROUND

• 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.

  PMID: 16206030 BACKGROUND

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

  PMID: 16734317 BACKGROUND

• 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.

  PMID: 15037415 BACKGROUND

• 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.

  PMID: 11249391 BACKGROUND

• 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.

  PMID: 5812581 BACKGROUND

• 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.

  PMID: 8842582 BACKGROUND

• Tuckwell P. Schooling the subnormal child. The Massachusetts System. Nurs Mirror Midwives J. 1975 Sep 18;141(12):73-4. No abstract available.

  PMID: 1042815 BACKGROUND

• 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.

  PMID: 16307962 BACKGROUND

• 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.

  PMID: 15157791 BACKGROUND

• 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.

  PMID: 15451331 BACKGROUND

• 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.

  PMID: 19370644 BACKGROUND

• 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. doi: 10.1016/s0029-7844(99)00524-4.

  PMID: 10674591 BACKGROUND

MeSH Terms

Conditions

Premenstrual Syndrome

Interventions

Desogestrel; ethinyl estradiol-desogestrel combination; drospirenone; drospirenone and ethinyl estradiol combination

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Jirath Wichianpitaya, M.D.

  Chulalongkorn University

  PRINCIPAL INVESTIGATOR

• Surasak Taneepanichskul, M.D.

  Chulalongkorn University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mr

Study Record Dates

• First Submitted: November 27, 2011
• First Posted: November 30, 2011
• Study Start: June 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: March 1, 2012
• Last Updated: March 14, 2012

Record last verified: 2012-03

Locations

TH (1)