Premenstrual Symptoms Treatment Comparing Between Oral Contraceptives Containing Desogestrel and Drospirenone

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jirath Wichianpitaya,MD., Chulalongkorn University
ClinicalTrials.gov Identifier:
NCT01482338
First received: November 27, 2011
Last updated: March 13, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Premenstrual Syndrome
Drug: EE 20 microgram with desogestrel 150 mg
Drug: EE 20 microgram with drospirenone 3 mg
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Comparative Efficacy of Low-dose Combine Oral Contraceptives Containing Desogestrel 150 mg and Drospirenone 3 mg on Premenstrual Symptoms

Resource links provided by NLM:


Further study details as provided by Chulalongkorn University:

Primary Outcome Measures:
  • Women's Health Assessment Questionnaire (WHAQ)score [ Time Frame: 8 months ] [ Designated as safety issue: No ]

Enrollment: 90
Study Start Date: June 2011
Study Completion Date: March 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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.
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

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

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01482338

Locations
Thailand
Family Unit, King Chulalongkorn Memorial Hospital
Bangkok, Thailand, 10330
Sponsors and Collaborators
Chulalongkorn University
Investigators
Principal Investigator: Jirath Wichianpitaya, M.D. Chulalongkorn University
Study Chair: Surasak Taneepanichskul, M.D. Chulalongkorn University
  More Information

Additional Information:
Publications:

Responsible Party: Jirath Wichianpitaya,MD., Mr, Chulalongkorn University
ClinicalTrials.gov Identifier: NCT01482338     History of Changes
Other Study ID Numbers: PMS 068/54
Study First Received: November 27, 2011
Last Updated: March 13, 2012
Health Authority: Thailand: Ethical Committee

Keywords provided by Chulalongkorn University:
PMS
Low-dose combine contraceptives pills
COC

Additional relevant MeSH terms:
Premenstrual Syndrome
Menstruation Disturbances
Pathologic Processes
Contraceptive Agents
Desogestrel
Contraceptives, Oral
Contraceptives, Oral, Combined
Ethinyl Estradiol
Drospirenone
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Aldosterone Antagonists
Hormone Antagonists
Progestins
Contraceptives, Oral, Synthetic

ClinicalTrials.gov processed this record on April 22, 2014