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Int J Clin Exp Med 2013;6(1):67-73
Original Article
Oral continuous combined 0·5 mg estradiol valerate and 5 mg dydrogesterone as
daily add-back therapy during post-operative GnRH agonist treatment for
endometriosis in Chinese women
Shien Zou, Qiqi Long, Shaofen Zhang, Yi Han, Wei Zhang
Department of Gynecology, Obstetrics and Gynecology Hospital of Fudan University, Shanghai 200011, China; Department of
Biostatistics, School of Public Health, Fudan University, Shanghai 200032, China
Received October 13, 2012; accepted November 5, 2012; Epub November 30,2012, 2012; Published January 1, 2013
Abstract: Objective: To evaluate the lowest effective dose of combined estrogen and progestogen (E2+P) add-back therapy during
post-operative gonadotropin-releasing hormone agonist (GnRHa) treatment for endometriosis in Chinese women. Study design: The
study enrolled 81 patients aged 18 to 50 years with stage III or IV endometriosis, as diagnosed by surgery. All patients were given
GnRHa 3·6 mg by subcutaneous injection once every 28 days for a total of three times. Patients were divided into three groups: the first
(n = 35; GnRHa only group) received GnRHa only without add-back therapy, the second (n = 35; 0·5 mg E2+P add-back group) received
GnRHa plus 0·5 mg estradiol valerate and 5 mg dydrogesterone orally every day, and the third (n = 11; 1 mg E2+P add-back group)
received GnRHa plus 1 mg estradiol valerate and 10 mg dydrogesterone orally every day for the duration of treatment. All patients were
required to follow up at our hospital at 4, 8 and 12 weeks after treatment initiation to assess efficacy and levels of serum reproductive
hormones. Results: Compared with baseline levels, serum levels of the four reproductive hormones assessed (E2, LH, P4 and FSH)
were significantly decreased in both the GnRHa only and the 0·5 mg E2+P add-back groups at 4, 8, and 12 weeks after treatment; and
levels reached a stable state at 4 weeks of treatment. In the 1 mg E2+P add-back group, LH and FSH serum levels were significantly
decreased, while those of E2 and P were not significantly different at any of the time points assessed. In the 0·5 mg E2+P add-back
group, E2 serum levels decreased drastically at first, then gradually over the course of the study. In contrast, pre- and post-treatment E2
serum levels in the 1 mg E2+P add-back group were not significantly different, and these levels were over 45 pg/mL for the entire study
duration. Comparison among groups showed that E2 levels in both add-back groups were significantly higher than in the GnRHa only
group at 12 weeks after treatment. Furthermore, E2 serum levels in the two add-back groups at 8 and 12 weeks after treatment were
significantly different. Conclusion: Oral continuous combined 0·5 mg/d estradiol valerate and 5 mg/d dydrogesterone as immediate
add-back therapy during post-operative GnRH agonist treatment for severe endometriosis may be the most suitable regimen for
Chinese women. (IJCEM1210005).
Keywords: Endometriosis, GnRH agonist, ultra-low dose estrogen, immediate add-back therapy
Address all correspondence to:
Dr. Shaofen Zhang
The Obs/Gyn Hospital of Fudan University
128 Shenyang Rd. Shanghai 200090, China.
Tel: 0086 13501831796; Fax: 0086 21 63455090
E-mail: zhangshaofen@163.com
Original Article
Oral continuous combined 0·5 mg estradiol valerate and 5 mg dydrogesterone as
daily add-back therapy during post-operative GnRH agonist treatment for
endometriosis in Chinese women
Shien Zou, Qiqi Long, Shaofen Zhang, Yi Han, Wei Zhang
Department of Gynecology, Obstetrics and Gynecology Hospital of Fudan University, Shanghai 200011, China; Department of
Biostatistics, School of Public Health, Fudan University, Shanghai 200032, China
Received October 13, 2012; accepted November 5, 2012; Epub November 30,2012, 2012; Published January 1, 2013
Abstract: Objective: To evaluate the lowest effective dose of combined estrogen and progestogen (E2+P) add-back therapy during
post-operative gonadotropin-releasing hormone agonist (GnRHa) treatment for endometriosis in Chinese women. Study design: The
study enrolled 81 patients aged 18 to 50 years with stage III or IV endometriosis, as diagnosed by surgery. All patients were given
GnRHa 3·6 mg by subcutaneous injection once every 28 days for a total of three times. Patients were divided into three groups: the first
(n = 35; GnRHa only group) received GnRHa only without add-back therapy, the second (n = 35; 0·5 mg E2+P add-back group) received
GnRHa plus 0·5 mg estradiol valerate and 5 mg dydrogesterone orally every day, and the third (n = 11; 1 mg E2+P add-back group)
received GnRHa plus 1 mg estradiol valerate and 10 mg dydrogesterone orally every day for the duration of treatment. All patients were
required to follow up at our hospital at 4, 8 and 12 weeks after treatment initiation to assess efficacy and levels of serum reproductive
hormones. Results: Compared with baseline levels, serum levels of the four reproductive hormones assessed (E2, LH, P4 and FSH)
were significantly decreased in both the GnRHa only and the 0·5 mg E2+P add-back groups at 4, 8, and 12 weeks after treatment; and
levels reached a stable state at 4 weeks of treatment. In the 1 mg E2+P add-back group, LH and FSH serum levels were significantly
decreased, while those of E2 and P were not significantly different at any of the time points assessed. In the 0·5 mg E2+P add-back
group, E2 serum levels decreased drastically at first, then gradually over the course of the study. In contrast, pre- and post-treatment E2
serum levels in the 1 mg E2+P add-back group were not significantly different, and these levels were over 45 pg/mL for the entire study
duration. Comparison among groups showed that E2 levels in both add-back groups were significantly higher than in the GnRHa only
group at 12 weeks after treatment. Furthermore, E2 serum levels in the two add-back groups at 8 and 12 weeks after treatment were
significantly different. Conclusion: Oral continuous combined 0·5 mg/d estradiol valerate and 5 mg/d dydrogesterone as immediate
add-back therapy during post-operative GnRH agonist treatment for severe endometriosis may be the most suitable regimen for
Chinese women. (IJCEM1210005).
Keywords: Endometriosis, GnRH agonist, ultra-low dose estrogen, immediate add-back therapy
Address all correspondence to:
Dr. Shaofen Zhang
The Obs/Gyn Hospital of Fudan University
128 Shenyang Rd. Shanghai 200090, China.
Tel: 0086 13501831796; Fax: 0086 21 63455090
E-mail: zhangshaofen@163.com
