Using a Danazol-Loaded IUD for Treatment of Uterine Adenomyosis

Title: “Novel Conservative Medical Therapy for Uterine Adenomyosis: Danazol-Loaded IUD Therapy” 
Presentation Authors: 1,2,3M. Igarashi, 1M. Fukada, 1Y. Nogami, 2A. Ando, 2M. Miyasaka, 2Y. Taguchi and 3M. Yoshida 
Affiliation: 1Gunma Central General Hospital, Maebashi, 2Ohmiya Red Cross Hospital, Ohmiya, and 3Fujioka General Hospital, Fujioka, Japan.

Summary written by Christine Schroeder, Ph.D.

Uterine adenomyosis is a condition in which endometriosis has infiltrated the walls of the uterus. It can be treated via hysterectomy, but this is not a viable option in women who wish to retain their fertility. Because of the inhibitory effect that the drug danazol has shown on endometriosis cells, the researchers investigated the efficacy of a temporary danazol-loaded IUD that was inserted into the uterus. The IUD was constructed of a plastic that released the danazol over time.

The participants in the study were nine women with adenomyosis who had not responded to oral danazol therapy or nasal GnRH analog therapy. The danazol-loaded IUI was inserted into the uterus and removed four to seven months later. The outcome measures of interest included:

Myometrium thickness 
CA125 levels 
Painful or heavy menses 
 

The results demonstrated that:

• Ultrasound imaging showed myometrium thickness to be reduced within five weeks in five patients and three more patients had reduced thickness within 12 weeks 
• Serum CA125 levels decreased within four weeks for three patients and within seven weeks in a fourth patient 
• Painful and heavy periods improved within six weeks for all nine patients 
• The side effects of systemic (oral) danazol therapy were not present in any of the patients, and serum danazol levels were undetectable in the patients on the IUD. In contrast, past studies of patients on oral danazol therapy had found serum danazol levels of 100 ng/mL and up. 
• Four of the patients had been experiencing infertility and, within 9 weeks of IUD removal, two of these patients became pregnant. 

Based on these results, the researchers concluded that:

• Among patients resistant to oral danazol therapy and nasal GnRH agonist therapy, a danazol-loaded IUD treatment can be very effective and is much more conservative than a hysterectomy 
• The subjective and objective signs and symptoms of adenomyoma were reduced or eliminated in the majority of participants in a minimal amount of time 
• Conception can occur after removal of the IUD 
• Systemic side effects do not occur because the danazol remains concentrated in the uterine area 
   

Note: Another very interesting talk. It should be noted that this research was done in Japan; I do not know what the acceptability of any type of IUD therapy would be among American doctors, since the IUD is generally more poorly regarded in the United States than it is in some other countries. In addition, because the danazol remains in the uterus, it does not affect endometriosis outside of the uterine walls.