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| ID | Type | Description | Link |
|---|---|---|---|
| 310787 | Other Identifier | Company Internal | |
| 2008-003226-42 | EudraCT Number |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EV/DNG (Qlaira, BAY86-5027) | Drug | Estradiol valerate (EV) and dienogest (DNG). Sequential 4-phasic regimen. Daily oral administration of one capsule SH T00658ID for 28 days per cycle for 6 treatment cycles no pill-free interval |
| Measure | Description | Time Frame |
|---|---|---|
| To compare SH T00658ID (Qlaira) to Microgynon with regard to changes in frequency and intensity of the hormone withdrawal associated symptoms headache and pelvic pain on cycle days 22-28 combined into a single endpoint | Baseline to cycle 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Rescue medication consumption | Baseline to cycle 6 | |
| Frequency and intensity of other hormone-related symptoms (bloating or swelling, breast tenderness, and nausea or vomiting) during cycle days 22 to 28 | Baseline to cycle 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ashfield | New South Wales | 2031 | Australia | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23919857 | Derived | 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. |
| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer Healthcare products conducted in Europe | View source |
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| Encapsulated Microgynon + Placebo | Drug | Day 1 to 21; 0.03 mg ethinylestradiol (EE) + 0.15 mg levonorgestrel (LNG). Day 22 to 28 placebo |
|
| Prevalence of individual hormone-related symptoms during cycle days 1 to 21 | Baseline to cycle 6 |
| Prevalence of individual hormone-related symptoms during hormone-free interval, i.e. cycle days 27+28 for EV/DNG capsules and cycle days 22 to 28 for the comparator | Baseline, cycle 3 and cycle 6 |
| Change in the average of the 3 highest VAS values of the hormone withdrawal associated symptoms pelvic pain or headache during cycle days 22 to 28 from baseline to cycle 3 | Baseline to cycle 3 |
| Bleeding pattern and cycle control | Throughout |
| QoL Questionnaires: Psychological General Well-Being Index (PGWBI), Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) and Clinical Global Index (CGI) | Baseline, cycle 2 and cycle 5 |
| AEs and SAEs. Concomitant medication. Vital signs (heart rate and blood pressure). Body weight | Throughout |
| General physical and gynecological examination | Screening and Final Visit |
| Blacktown |
| New South Wales |
| 2148 |
| Australia |
| Caringbah | New South Wales | 2229 | Australia |
| Sydney | New South Wales | 2031 | Australia |
| Fortitude Valley | Queensland | 4006 | Australia |
| Kipparing | Queensland | 4021 | Australia |
| Adelaide | South Australia | 5005 | Australia |
| Norwood | South Australia | 5065 | Australia |
| Clayton | Victoria | 3163 | Australia |
| Nedlands | Western Australia | 6009 | Australia |
| Subiaco | Western Australia | 6008 | Australia |
| Helsinki | 00100 | Finland |
| Helsinki | 00260 | Finland |
| Helsinki | 00350 | Finland |
| Kuopio | 70100 | Finland |
| Kuopio | 70110 | Finland |
| Paris | Paris | 75018 | France |
| Brignoles | 83170 | France |
| Maison Lafitte | 78600 | France |
| Nancy | 54042 | France |
| Nantes | 44000 | France |
| Nantes | 44093 | France |
| Olivet | 45160 | France |
| Paris | 75007 | France |
| Paris | 75015 | France |
| Saint-Germain-en-Laye | 78100 | France |
| Seclin | 59113 | France |
| Tarare | 69170 | France |
| Toulouse | 31000 | France |
| Rheinstetten | Baden-Wurttemberg | 76287 | Germany |
| Hamburg | Free and Hanseatic City of Hamburg | 22359 | Germany |
| Frankfurt am Main | Hesse | 60322 | Germany |
| Hanover | Lower Saxony | 30459 | Germany |
| Bochum | North Rhine-Westphalia | 44787 | Germany |
| Essen | North Rhine-Westphalia | 45127 | Germany |
| Wuppertal | North Rhine-Westphalia | 42103 | Germany |
| Dresden | Saxony | 01067 | Germany |
| Leipzig | Saxony | 04103 | Germany |
| Magdeburg | Saxony-Anhalt | 39126 | Germany |
| Lübeck | Schleswig-Holstein | 23538 | Germany |
| Hermosillo | Sonora | 83100 | Mexico |
| México | State of Mexico | 06700 | Mexico |
| Mexico City | 3100 | Mexico |
| México, D.F. | 07760 | Mexico |
| Benidorm | Alicante | 03503 | Spain |
| Petrel | Alicante | 03610 | Spain |
| Barcelona | Barcelona | 08013 | Spain |
| Barcelona | Catalonia | 08003 | Spain |
| Madrid | Madrid | 28001 | Spain |
| Gijón | Principality of Asturias | 33212 | Spain |
| Basel | Canton of Basel-City | 4031 | Switzerland |
| Bern | Canton of Bern | 3010 | Switzerland |
| Zurich | Canton of Zurich | 8091 | Switzerland |
| Bern | 3013 | Switzerland |
| Bangkok | 10330 | Thailand |
| Bangkok | 10400 | Thailand |
| Bangkok | 10700 | Thailand |
| Cheadle | Cheshire | SK8 5LL | United Kingdom |
| Northwood | Middlesex | HA6 2RN | United Kingdom |
| Weston-super-Mare | North Somerset | BS23 4BP | United Kingdom |
| Nottingham | Nottinghamshire | NG2 4PJ | United Kingdom |
| Glasgow | Stratchclyde | G45 9AW | United Kingdom |
| London | W12 0NN | United Kingdom |
| ID | Term |
|---|---|
| D006261 | Headache |
| D017699 | Pelvic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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