• To assess contraceptive efficacy, vaginal bleeding patterns (cycle control),general safety and acceptability of the NOMAC-E2 COC in a large group ofwomen aged 18-50 years.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
contraceptie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
-To assess contraceptive efficacy, vaginal bleeding patterns( cycle control),
general safety and acceptability of the NOMAC-E2 COC in a large group of women
aged 18-50 years
Secondary outcome
- To evaluate the effects of the NOMAC-E2 COC on satisfaction and health
related quality of life, libido, acne, menstrual symptoms and body weight;
- To explore the aforementioned characteristics of the NOMAC-E2 COC in
comparison with the DRSP-EE COC.
Background summary
The NOMAC/E2 COC contains the natural 17 B estradiol ( E2) and the nomegestrol
acetate as progestagen. It is generally perceived that an E2 containing COC
will be associated with a more favorable safety profile than EE containing
COCs.
Study objective
• To assess contraceptive efficacy, vaginal bleeding patterns (cycle control),
general safety and acceptability of the NOMAC-E2 COC in a large group of
women aged 18-50 years.
Study design
This is a randomized, open-label, comparative trial. In total 2080 women
between 18 and 50 years old will participate in this trial. Women who qualify
for participation will be randomised, after they have given their permission
and they have been screened, for treatment with NOMAC E2 pill (1.5 mg estradiol
(E2) and 2.5 mg nomegestrol acetate (NOMAC) or the DRSP-EE pill (3.0 mg
drospirenone and 30 µg ethinylestradiol). The treatment period will consist of
13 cycles.
Intervention
NOMAC/E2 ( 2,5 mg nomegestrol acetate /1,5 mg oestradiol) combined oral
contraceptive
or
DRSP/EE ( 3 mg drospirenone/ 30 ug ethinyl estradiol) combined oral
contraceptive
Study burden and risks
Healthy fertile women will be treated during 13 cycles with NOMAC-E2 COC or
the DRSP-EE COC. The discomfort consists mainly out of 6 visits to the clinic
(6 weeks after the 6th visit the subject will be contacted by telephone or
visit at clinic), electronic diary, questionnaires, blood samples, breast
examination, cervical smear en physical / gynaecological examination. The
subjects will get extensively check ups, a lot of information and a
compensation for costs for time, eventual discomforts and travelling.
Griekenweg 25
5340 AM Oss
Nederland
Griekenweg 25
5340 AM Oss
Nederland
Listed location countries
Age
Inclusion criteria
Healthy Sexually active women at risk for pregnancy and not planning to use condoms
Women in need for contraception and willing to use an Oral Contraceptive
Age at least 18 - 50 years
Exclusion criteria
Contraindications for contraceptive steroids
Additional contraindications related to the antimineralocorticoid activity of drospirenone
Abnormal cervical smear at screening
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2005-005304-16-NL |
| CCMO | NL11756.040.06 |
| Other | zie www.organon-trials.com |