Clinical trial
A Randomized, Open-Label, Controlled, Multi-Center Trial to Evaluate the Contraceptive Efficacy, Cycle Control, Safety and Acceptability of NuvaRing® (SCH 900702) in Chinese Women
Name
P06450
Description
This is a study to assess the effectiveness of NuvaRing® (SCH 900702) for the prevention of pregnancy in fertile Chinese women. The acceptability and safety of NuvaRing® will also be assessed and compared with that of Yasmin.
Trial arms
Trial start
2011-09-19
Estimated PCD
2013-09-18
Trial end
2013-09-18
Status
Completed
Phase
Early phase I
Treatment
ENG 120 µg + EE 15 µg intravaginal ring
13 cycles of ENG-EE (NuvaRing) vaginal ring use. Each cycle 28 days, with a 21-day active treatment period followed by 7-day ring-free period. One ring per cycle, each ring containing 11.7 mg ENG and 2.7 mg EE, and releasing on average 120 mcg/day of ENG and 15 mcg/day of EE.
Arms:
ENG-EE (NuvaRing)
Other names:
NuvaRing
DRSP 3 mg + EE 30 µg
13 cycles of DRSP-EE tablet use. Each cycle 28 days, with a 21-day active treatment period followed by a 7-day tablet-free period. Participants received total of 21 tablets per cycle, each tablet contained 3 mg DRSP and 30 μg EE.
Arms:
DRSP-EE
Other names:
Yasmin
Size
983
Primary endpoint
Pearl Index, by Treatment Group
Up to 1 year
Eligibility criteria
Key Inclusion Criteria:
* Sexually active Chinese women, at risk for pregnancy and not planning to use condoms during trial medication use
* Women in need for contraception and willing to use a hormonal contraceptive method for 13 cycles
* Body mass index ≥18 and ≤29 kg/m\^2
Key Exclusion Criteria:
* Contraindications for contraceptive steroids
* Abnormal cervical smear corresponding to indeterminate changes at screening
* Clinically relevant abnormal laboratory result at screening as judged by the investigator.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 983, 'type': 'ACTUAL'}}
Updated at
2024-05-24
1 organization
2 products
1 indication
Organization
Organon and CoIndication
ContraceptionProduct
DRSP 3 mg + EE 30 µg