Trial Outcomes & Findings for Long-term Active Surveillance Study for Oral Contraceptives (LASS) (NCT NCT00676065)

Last Updated: 2014-11-19

Results Overview

Arterial thromboembolism associated with the use of oral contraceptives containing drospirenone or levonorgestrel or other progestogens.

Recruitment status

COMPLETED

Target enrollment

58303 participants

Primary outcome timeframe

Within 10 years

Results posted on

2014-11-19

Participant Flow

In the LASS study, 59,510 women were recruited overall. Of these, 836 participants were excluded due to protocol violation (e.g. patient did not start OC use). Furthermore, 371 patients started treatment with non-oral contraceptives. These patients were followed-up but were not part of the per protocol Population (58,303 patients).

Participant milestones

Participant milestones
Measure	Yasmin Users of oral contraceptives containing 3 mg DRSP and 30 mcg ethinylestradiol	OC-LNG Users of oral contraceptives containing levonorgestrel	OC-other Users of oral contraceptives containing other progestogens
Overall Study STARTED	16534	15428	26341
Overall Study COMPLETED	16534	15428	26341
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Long-term Active Surveillance Study for Oral Contraceptives (LASS)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DRSP/EE n=16534 Participants Users of oral contraceptives containing 3 mg DRSP and 30 mcg ethinylestradiol	OC-LNG n=15428 Participants Users of oral contraceptives containing levonorgestrel	OC-other n=26341 Participants Users of oral contraceptives containing other progestogens	Total n=58303 Participants Total of all reporting groups
Age, Continuous	25.9 years STANDARD_DEVIATION 8.1 • n=93 Participants	25.1 years STANDARD_DEVIATION 8.7 • n=4 Participants	24.8 years STANDARD_DEVIATION 7.8 • n=27 Participants	25.2 years STANDARD_DEVIATION 8.2 • n=483 Participants
Sex: Female, Male Female	16534 Participants n=93 Participants	15428 Participants n=4 Participants	26341 Participants n=27 Participants	58303 Participants n=483 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Region of Enrollment Europe	16534 participants n=93 Participants	15428 participants n=4 Participants	26341 participants n=27 Participants	58303 participants n=483 Participants

PRIMARY outcome

Timeframe: Within 10 years

Population: The number of participants refers to the ITT study population. During the course od the study, women could for example stop use of oral contraception at any point of time. Therefore, the woman-years of exposure for each group are provided in addition.

Arterial thromboembolism associated with the use of oral contraceptives containing drospirenone or levonorgestrel or other progestogens.

Outcome measures

Outcome measures
Measure	DRSP/EE n=52278 Woman-years, AT-population Users of oral contraceptives containing 3 mg DRSP and 30 mcg ethinylestradiol	OC-LNG n=57539 Woman-years, AT-population Users of oral contraceptives containing levonorgestrel	OC-other n=106221 Woman-years, AT-population Users of oral contraceptives containing other progestogens
Arterial Thromboembolism	7 participants	22 participants	34 participants

PRIMARY outcome

Timeframe: Within 10 years

Venous thromboembolism associated with the use of oral contraceptives containing drospirenone or levonorgestrel or other progestogens.

Outcome measures

Outcome measures
Measure	DRSP/EE n=52278 Woman-years, AT population Users of oral contraceptives containing 3 mg DRSP and 30 mcg ethinylestradiol	OC-LNG n=57539 Woman-years, AT population Users of oral contraceptives containing levonorgestrel	OC-other n=106221 Woman-years, AT population Users of oral contraceptives containing other progestogens
Venous Thromboembolism	56 participants	53 participants	144 participants

PRIMARY outcome

Timeframe: Within 10 years

Breast cancer associated with the use of hormonal contraceptives either containing both drospirenone (DRSP) and ethinylestradiol (EE), levonorgestrel (LNG) or any other hormonal contraceptive without DRSP.

Outcome measures

Outcome measures
Measure	DRSP/EE n=52278 Woman-years Users of oral contraceptives containing 3 mg DRSP and 30 mcg ethinylestradiol	OC-LNG n=57539 Woman-years Users of oral contraceptives containing levonorgestrel	OC-other n=106221 Woman-years Users of oral contraceptives containing other progestogens
Breast Cancer	27 participants	31 participants	45 participants

Adverse Events

DRSP/EE

Serious events: 1912 serious events

Other events: 0 other events

Deaths: 0 deaths

OC-LNG

Serious events: 2121 serious events

Other events: 0 other events

Deaths: 0 deaths

OC-other

Serious events: 3936 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Adverse event data not reported

Additional Information

Juergen Dinger, MD, PhD

Center for Epidemiology and Health Research Germany

Phone: +49 30 945 101 20

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	DRSP/EE n=16534 participants at risk Users of oral contraceptives containing 3 mg DRSP and 30 mcg ethinylestradiol	OC-LNG n=15428 participants at risk Users of oral contraceptives containing levonorgestrel	OC-other n=26341 participants at risk Users of oral contraceptives containing other progestogens
Infections and infestations Infectious diseases	0.52% 86/16534 • Information on adverse events was collected over a time period of 10 years. ITT population. All study participants were asked for adverse events at each follow-up.	0.56% 86/15428 • Information on adverse events was collected over a time period of 10 years. ITT population. All study participants were asked for adverse events at each follow-up.	0.65% 171/26341 • Information on adverse events was collected over a time period of 10 years. ITT population. All study participants were asked for adverse events at each follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms, malignant	0.36% 59/16534 • Information on adverse events was collected over a time period of 10 years. ITT population. All study participants were asked for adverse events at each follow-up.	0.47% 72/15428 • Information on adverse events was collected over a time period of 10 years. ITT population. All study participants were asked for adverse events at each follow-up.	0.47% 124/26341 • Information on adverse events was collected over a time period of 10 years. ITT population. All study participants were asked for adverse events at each follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms, benign	0.58% 96/16534 • Information on adverse events was collected over a time period of 10 years. ITT population. All study participants were asked for adverse events at each follow-up.	0.63% 97/15428 • Information on adverse events was collected over a time period of 10 years. ITT population. All study participants were asked for adverse events at each follow-up.	0.68% 179/26341 • Information on adverse events was collected over a time period of 10 years. ITT population. All study participants were asked for adverse events at each follow-up.
Blood and lymphatic system disorders Diseases of the blood and the bloodforming organs	0.04% 7/16534 • Information on adverse events was collected over a time period of 10 years. ITT population. All study participants were asked for adverse events at each follow-up.	0.06% 9/15428 • Information on adverse events was collected over a time period of 10 years. ITT population. All study participants were asked for adverse events at each follow-up.	0.07% 18/26341 • Information on adverse events was collected over a time period of 10 years. ITT population. All study participants were asked for adverse events at each follow-up.
Endocrine disorders Endocrine diseases	0.30% 50/16534 • Information on adverse events was collected over a time period of 10 years. ITT population. All study participants were asked for adverse events at each follow-up.	0.48% 74/15428 • Information on adverse events was collected over a time period of 10 years. ITT population. All study participants were asked for adverse events at each follow-up.	0.36% 96/26341 • Information on adverse events was collected over a time period of 10 years. ITT population. All study participants were asked for adverse events at each follow-up.
Psychiatric disorders Psychiatric & neurological disorders	0.69% 114/16534 • Information on adverse events was collected over a time period of 10 years. ITT population. All study participants were asked for adverse events at each follow-up.	0.88% 136/15428 • Information on adverse events was collected over a time period of 10 years. ITT population. All study participants were asked for adverse events at each follow-up.	1.0% 274/26341 • Information on adverse events was collected over a time period of 10 years. ITT population. All study participants were asked for adverse events at each follow-up.
Eye disorders Eye	0.11% 19/16534 • Information on adverse events was collected over a time period of 10 years. ITT population. All study participants were asked for adverse events at each follow-up.	0.16% 24/15428 • Information on adverse events was collected over a time period of 10 years. ITT population. All study participants were asked for adverse events at each follow-up.	0.15% 40/26341 • Information on adverse events was collected over a time period of 10 years. ITT population. All study participants were asked for adverse events at each follow-up.
Ear and labyrinth disorders Ear	0.15% 24/16534 • Information on adverse events was collected over a time period of 10 years. ITT population. All study participants were asked for adverse events at each follow-up.	0.18% 28/15428 • Information on adverse events was collected over a time period of 10 years. ITT population. All study participants were asked for adverse events at each follow-up.	0.20% 53/26341 • Information on adverse events was collected over a time period of 10 years. ITT population. All study participants were asked for adverse events at each follow-up.
Cardiac disorders Cardiovascular system	1.2% 198/16534 • Information on adverse events was collected over a time period of 10 years. ITT population. All study participants were asked for adverse events at each follow-up.	1.5% 226/15428 • Information on adverse events was collected over a time period of 10 years. ITT population. All study participants were asked for adverse events at each follow-up.	1.6% 425/26341 • Information on adverse events was collected over a time period of 10 years. ITT population. All study participants were asked for adverse events at each follow-up.
Respiratory, thoracic and mediastinal disorders Respiratory system	0.34% 56/16534 • Information on adverse events was collected over a time period of 10 years. ITT population. All study participants were asked for adverse events at each follow-up.	0.41% 64/15428 • Information on adverse events was collected over a time period of 10 years. ITT population. All study participants were asked for adverse events at each follow-up.	0.49% 128/26341 • Information on adverse events was collected over a time period of 10 years. ITT population. All study participants were asked for adverse events at each follow-up.
Gastrointestinal disorders Digestive system	1.5% 248/16534 • Information on adverse events was collected over a time period of 10 years. ITT population. All study participants were asked for adverse events at each follow-up.	1.7% 265/15428 • Information on adverse events was collected over a time period of 10 years. ITT population. All study participants were asked for adverse events at each follow-up.	1.9% 503/26341 • Information on adverse events was collected over a time period of 10 years. ITT population. All study participants were asked for adverse events at each follow-up.
Skin and subcutaneous tissue disorders Skin	0.50% 82/16534 • Information on adverse events was collected over a time period of 10 years. ITT population. All study participants were asked for adverse events at each follow-up.	0.63% 97/15428 • Information on adverse events was collected over a time period of 10 years. ITT population. All study participants were asked for adverse events at each follow-up.	0.76% 200/26341 • Information on adverse events was collected over a time period of 10 years. ITT population. All study participants were asked for adverse events at each follow-up.
Musculoskeletal and connective tissue disorders Muscoskeletal system & connective tissue	1.2% 206/16534 • Information on adverse events was collected over a time period of 10 years. ITT population. All study participants were asked for adverse events at each follow-up.	1.5% 233/15428 • Information on adverse events was collected over a time period of 10 years. ITT population. All study participants were asked for adverse events at each follow-up.	1.5% 403/26341 • Information on adverse events was collected over a time period of 10 years. ITT population. All study participants were asked for adverse events at each follow-up.
Reproductive system and breast disorders Genitourinary system	1.7% 279/16534 • Information on adverse events was collected over a time period of 10 years. ITT population. All study participants were asked for adverse events at each follow-up.	1.9% 290/15428 • Information on adverse events was collected over a time period of 10 years. ITT population. All study participants were asked for adverse events at each follow-up.	2.2% 572/26341 • Information on adverse events was collected over a time period of 10 years. ITT population. All study participants were asked for adverse events at each follow-up.
Pregnancy, puerperium and perinatal conditions Pregnancy, delivery & puerperium	0.31% 51/16534 • Information on adverse events was collected over a time period of 10 years. ITT population. All study participants were asked for adverse events at each follow-up.	0.40% 62/15428 • Information on adverse events was collected over a time period of 10 years. ITT population. All study participants were asked for adverse events at each follow-up.	0.38% 99/26341 • Information on adverse events was collected over a time period of 10 years. ITT population. All study participants were asked for adverse events at each follow-up.
Injury, poisoning and procedural complications Injury, poisoning, accidents, etc.	2.0% 337/16534 • Information on adverse events was collected over a time period of 10 years. ITT population. All study participants were asked for adverse events at each follow-up.	2.3% 358/15428 • Information on adverse events was collected over a time period of 10 years. ITT population. All study participants were asked for adverse events at each follow-up.	2.5% 651/26341 • Information on adverse events was collected over a time period of 10 years. ITT population. All study participants were asked for adverse events at each follow-up.