Effect of a New Oral Contraceptive Pill on Hormone Related Symptoms Such as Pelvic Pain and Headache

Phase 3 Completed 449 enrolled Bayer

RandomizedParallel-groupDouble-blindPrevention

Summary

The aim of the present study is to investigate whether women taking a new combined oral contraceptive pill (SH T00658ID, estradiol valerate/dienogest) experience fewer hormone withdrawal-associated symptoms such as pelvic pain or headache during their monthly cycle compared to a commonly used contraceptive pill (Microgynon).

Timeline

Start: 2008-12
Primary completion: 2010-12
Completion: 2010-12

Publications

Macias G, Merki-Feld GS, Parke S, Mellinger U, Serrani M. Effects of a combined oral contraceptive containing oestradiol valerate/dienogest on hormone withdrawal-associated symptoms: results from the multicentre, randomised, double-blind, active-controlled HARMONY II study. J Obstet Gynaecol. 2013 Aug;33(6):591-6. doi: 10.3109/01443615.2013.800851.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dienogest	Small molecule	—	Oral
Comparator	Levonorgestrel	Small molecule	0.15 mg	—
Subject	estradiol valerate	Unknown	—	Oral
Comparator	ethinyl estradiol	Small molecule	0.03 mg	—

Effect of a New Oral Contraceptive Pill on Hormone Related Symptoms Such as Pelvic Pain and Headache

Summary

Timeline

Publications

Drugs

Indications