Favorite Datasets from Early (and Late) Phases of Drug Research

Oral Contraceptive Interaction Study

Part 4 - Table 6


Twenty-two female subjects (Sub) were allocated randomly to one of two treatment sequences (Seq) in a two period crossover design. The two treatment sequences were either drug (D) given in the first period followed by placebo (P) in the second treatment period (sequence D/P), or the reverse order was administered (P/D). In both treatment periods, a two component oral contraceptive was given. The components were ethinyl estradiol (EE) and norethindrone (NET) . The treatment periods were eight days in length and separated by the time between two menstrual cycles.

On day 8 of each treatment period, blood samples were drawn at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours after drug (or placebo) dosing. From these, the area under the plasma concentration vs. time curve (AUC) and the maximum plasma concentration (Cmax) were calculated for each component (EE and NET) of the oral contraceptive.

When comparing the drug results to the placebo results, a 20% difference in either Cmax or AUC would provide evidence of a drug-oral contraceptive interaction.

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Part 4 - Table 6
Oral Contraceptive Interaction Study
Ethinyl Estradiol (EE) Norethindrone (NET)
AUC Cmax AUC Cmax
(pg * hr/ml) (pg/ml) (pg * hr/ml) (pg/ml)
Sub Seq Drug Pbo Drug Pbo Drug Pbo Drug Pbo
1 P/D 3744.8 2623.0 366 279 197117.5 197525.0 21600 21900
2 D/P 3756.2 2511.0 300 172 176487.5 198357.5 25100 23300
3 P/D 2480.0 2227.7 253 252 184745.0 151957.5 22900 23200
4 D/P 2986.9 3177.2 284 295 116305.0 133092.5 16400 18100
5 D/P 3858.2 3176.9 467 373 125869.0 156413.8 21600 22400
6 P/D 4642.2 4493.7 435 513 164875.0 156367.5 13400 17200
7 P/D 2879.7 2985.3 298 313 195862.5 184942.5 20800 24300
8 D/P 3328.1 2941.4 431 302 118340.0 148220.0 18100 24200
9 D/P 3005.8 3033.9 306 288 176590.0 205315.0 17800 54200
10 P/D 2498.4 1919.7 325 243 138015.0 123012.5 22400 20500
11 P/D 2266.6 2496.1 190 227 155122.5 122987.5 10100 14300
12 D/P 5624.5 5044.3 651 591 207327.5 190987.5 26600 28200
13 P/D 3514.8 3016.0 324 317 176055.0 173565.0 25500 24900
14 D/P 3354.9 2343.5 326 292 197912.5 206160.0 40100 31300
15 P/D 3214.7 2985.2 277 303 186815.0 156367.5 21300 21300
16 D/P 3282.8 2383.1 314 335 182250.0 199877.5 21800 26700
17 P/D 3580.9 3385.5 349 369 204687.5 201557.5 25600 34400
18 D/P 5018.0 4161.7 462 500 278532.5 271885.0 24200 36600
19 P/D 2982.8 2622.0 283 266 189285.0 155790.0 16300 19400
20 D/P 2472.0 1936.7 370 204 86467.5 93730.0 12700 13200
21 D/P 3819.6 2760.7 335 389 142359.8 150215.0 24600 28000
22 P/D 4333.3 3863.5 362 288 253460.0 232197.5 27200 28600


Source:

Bradstreet, T.E. and Liss, C.L. (1995) "Favorite Data Sets from Early (and Late) Phases of Drug Research - Part 4." Proceedings of the Section on Statistical Education of the American Statistical Association.

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Last modified July 27, 2010 - THS