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Completed

NCT Number: NCT01482338

Premenstrual Symptoms Treatment Comparing Between Oral Contraceptives Containing Desogestrel and Drospirenone

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.

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Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Family Unit, King Chulalongkorn Memorial Hospital

Bangkok, 10330, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Mercilon

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.

Other names: Yaz

Primary outcomes

  1. Women's Health Assessment Questionnaire (WHAQ)score

    Time frame: 8 months

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 30, 2011
Registry last updated
Mar 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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