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

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT00778609

Collaborator

(none)

449

Enrollment

Locations

Arms

Duration (Months)

7.1

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Oral Contraceptive Headache Pelvic Pain	Drug: EV/DNG (Qlaira, BAY86-5027) Drug: Encapsulated Microgynon + Placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

449 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

Official Title:

A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Group, 2-arm Study to Show Superiority of the Oral Contraceptive SH T00658ID Over Microgynon on Hormone Withdrawal-associated Symptoms After 6 Cycles of Treatment

Study Start Date :

Dec 1, 2008

Actual Primary Completion Date :

Dec 1, 2010

Actual Study Completion Date :

Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1	Drug: EV/DNG (Qlaira, BAY86-5027) 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
Active Comparator: Arm 2	Drug: Encapsulated Microgynon + Placebo Day 1 to 21; 0.03 mg ethinylestradiol (EE) + 0.15 mg levonorgestrel (LNG). Day 22 to 28 placebo

Arm

Intervention/Treatment

Experimental: Arm 1

Drug: EV/DNG (Qlaira, BAY86-5027)

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

Active Comparator: Arm 2

Drug: Encapsulated Microgynon + Placebo

Day 1 to 21; 0.03 mg ethinylestradiol (EE) + 0.15 mg levonorgestrel (LNG). Day 22 to 28 placebo

Outcome Measures

Primary Outcome Measures

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]

Secondary Outcome Measures

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]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Age between 18 and 50 years (inclusive) at visit 1, for smokers up to 35 years (inclusive)
Otherwise healthy female subjects requesting contraception and currently using a levonorgestrel, gestodene or desogestrel containing oral contraceptive in a 21-day regimen and suffering from at least moderate pelvic pain, headache or both defined by an average value of >/= 35 mm for the 3 highest values on a visual analogue scale during cycle days 22-28.
Normal or clinically insignificant cervical smear not requiring further follow up (or a normal result obtained within the last 6 months before screening)
Able to tolerate ibuprofen and willing to use only ibuprofen supplied for the study.

Exclusion Criteria:

Women with any contraindication for oral contraceptive use

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Ashfield	New South Wales	Australia	2031
2	Blacktown	New South Wales	Australia	2148
3	Caringbah	New South Wales	Australia	2229
4	Sydney	New South Wales	Australia	2031
5	Fortitude Valley	Queensland	Australia	4006
6	Kipparing	Queensland	Australia	4021
7	Adelaide	South Australia	Australia	5005
8	Norwood	South Australia	Australia	5065
9	Clayton	Victoria	Australia	3163
10	Nedlands	Western Australia	Australia	6009
11	Subiaco	Western Australia	Australia	6008
12	Helsinki		Finland	00100
13	Helsinki		Finland	00260
14	Helsinki		Finland	00350
15	Kuopio		Finland	70100
16	Kuopio		Finland	70110
17	Brignoles		France	83170
18	Maison Lafitte		France	78600
19	Nancy		France	54042
20	Nantes		France	44000
21	Nantes		France	44093
22	Olivet		France	45160
23	Paris		France	75007
24	Paris		France	75015
25	Paris		France	75018
26	Saint Germain En Laye		France	78100
27	Seclin		France	59113
28	Tarare		France	69170
29	Toulouse		France	31000
30	Rheinstetten	Baden-Württemberg	Germany	76287
31	Frankfurt	Hessen	Germany	60322
32	Hannover	Niedersachsen	Germany	30459
33	Bochum	Nordrhein-Westfalen	Germany	44787
34	Essen	Nordrhein-Westfalen	Germany	45127
35	Wuppertal	Nordrhein-Westfalen	Germany	42103
36	Magdeburg	Sachsen-Anhalt	Germany	39126
37	Dresden	Sachsen	Germany	01067
38	Leipzig	Sachsen	Germany	04103
39	Lübeck	Schleswig-Holstein	Germany	23538
40	Hamburg		Germany	22359
41	Mexico	México	Mexico	06700
42	Hermosillo	Sonora	Mexico	83100
43	Mexico, D.F.		Mexico	3100
44	México, D.F.		Mexico	07760
45	Benidorm	Alicante	Spain	03503
46	Petrer	Alicante	Spain	03610
47	Gijón	Asturias	Spain	33212
48	Barcelona	Catalunya	Spain	08003
49	Barcelona		Spain	08013
50	Madrid		Spain	28001
51	Basel	Basel-Stadt	Switzerland	4031
52	Bern		Switzerland	3010
53	Bern		Switzerland	3013
54	Zürich		Switzerland	8091
55	Bangkok		Thailand	10330
56	Bangkok		Thailand	10400
57	Bangkok		Thailand	10700
58	Cheadle	Cheshire	United Kingdom	SK8 5LL
59	Northwood	Middlesex	United Kingdom	HA6 2RN
60	Weston-super-Mare	North Somerset	United Kingdom	BS23 4BP
61	Nottingham	Nottinghamshire	United Kingdom	NG2 4PJ
62	Glasgow	Stratchclyde	United Kingdom	G45 9AW
63	London		United Kingdom	W12 0NN